FDA event 84125 · Recall Observatory

device · product 1 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0421-2020

Recall number: Z-0421-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-SHETTY-050181-01 REF (GPN): G47168 Lot Number: NS9717356 UDI: (01)00827002471689(17)220516(10)NS9717356

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 2 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0422-2020

Recall number: Z-0422-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-65-P-NS-KMP-01 REF (GPN): G47185 Lot Number: 9908502 UDI: (01)00827002471856(17)220808(10)9908502

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 3 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0423-2020

Recall number: Z-0423-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-65-P-NS-TC-01 REF (GPN): G47192 Lot Number: 9903996 UDI: (01)00827002471924(17)220801(10)9903996

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 4 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0424-2020

Recall number: Z-0424-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 93

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB6.0-38-100-P-NS-JR4 REF (GPN): G04788 Lot Number: 9715474 UDI: (01)00827002047884(17)220516(10)9715474

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 5 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0425-2020

Recall number: Z-0425-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 165

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-SIM1 REF (GPN): G04922 Lot Numbers: 9700385, 9713001, 9726999 UDIs: (01)00827002049222(17)220509(10)9700385, (01)00827002049222(17)220516(10)9713001, (01)00827002049222(17)220515(10)9726999

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 6 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0426-2020

Recall number: Z-0426-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 80

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB7.0-38-65-P-NS-VERT REF (GPN): G05018 Lot Numbers: NS9880363, NS9890272, NS9933625 UDIs: (01)00827002050181(17)220731(10)NS9880363, (01)00827002050181(17)220805(10)NS9890272, (01)00827002050181(17)220812(10)NS9933625

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 7 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0427-2020

Recall number: Z-0427-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 791

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-JR4 REF (GPN): G05922 Lot Numbers: 9700390, 9705827, 9709327, 9710351, 9715466, 9715476, 9716493, 9716792, 9719152 UDIs: (01)00827002059221(17)220508(10)9700390, (01)00827002059221(17)220513(10)9705827, (01)00827002059221(17)220513(10)9709327, (01)00827002059221(17)220514(10)9710351, (01)00827002059221(17)220516(10)9715466, (01)00827002059221(17)220516(10)9715476, (01)00827002059221(17)220517(10)9716493, (01)00827002059221(17)220509(10)9716792, (01)00827002059221(17)220511(10)9719152

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 8 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0428-2020

Recall number: Z-0428-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 90

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-JL4 REF (GPN): G05923 Lot Numbers: 9700383, NS9701376 UDIs: (01)00827002059238(17)220510(10)9700383, (01)00827002059238(17)220508(10)NS9701376

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 9 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0429-2020

Recall number: Z-0429-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 585

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-JL3.5 REF (GPN): G05924 Lot Numbers: 9705826, 9707669, 9709326, 9714955, 9716791, 9717961, NS9718543 UDIs: (01)00827002059245(17)220516(10)9705826, (01)00827002059245(17)220513(10)9707669, (01)00827002059245(17)220515(10)9709326, (01)00827002059245(17)220516(10)9714955, (01)00827002059245(17)220510(10)9716791, (01)00827002059245(17)220511(10)9717961, (01)00827002059245(17)220516(10)NS9718543

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 10 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0430-2020

Recall number: Z-0430-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-110-P-6S-PIG REF (GPN): G05925 Lot Number: NS9708132 UDI: (01)00827002059252(17)220513(10)NS9708132

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 11 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0431-2020

Recall number: Z-0431-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-JR3.5 REF (GPN): G05928 Lot Number: 9707478 UDI: (01)00827002059283(17)220513(10)9707478

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 12 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0432-2020

Recall number: Z-0432-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 1,125

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-80-P-NS-C2 REF (GPN): G05955 Lot Numbers: 9916981, 9924484, 9924486, 9943478, 9943643, 9943644, 9944133, 9946873, 9946875, 9947569, 9949557, 9949558, 9952694, NS9938577 UDIs: (01)00827002059559(17)220805(10)9916981, (01)00827002059559(17)220807(10)9924484, (01)00827002059559(17)220807(10)9924486, (01)00827002059559(17)220823(10)9943478, (01)00827002059559(17)220822(10)9943643, (01)00827002059559(17)220822(10)9943644, (01)00827002059559(17)220822(10)9944133, (01)00827002059559(17)220822(10)9946873, (01)00827002059559(17)220823(10)9946875, (01)00827002059559(17)220822(10)9947569, (01)00827002059559(17)220822(10)9949557, (01)00827002059559(17)220823(10)9949558, (01)00827002059559(17)220823(10)9952694, (01)00827002059559(17)220816(10)NS9938577

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 13 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0433-2020

Recall number: Z-0433-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 20

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-65-P-NS-SHK1.0 REF (GPN): G05975 Lot Number: 9900974 UDI: (01)00827002059757(17)220730(10)9900974

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 14 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0434-2020

Recall number: Z-0434-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 405

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-SIM2 REF (GPN): G05976 Lot Numbers: 9700386, 9701378, 9707469, 9710399, 9713002 UDIs: (01)00827002059764(17)220511(10)9700386, (01)00827002059764(17)220510(10)9701378, (01)00827002059764(17)220514(10)9707469, (01)00827002059764(17)220510(10)9710399, (01)00827002059764(17)220516(10)9713002

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 15 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0435-2020

Recall number: Z-0435-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 30

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-65-P-NS-RIM REF (GPN): G05979 Lot Number: 9890936 UDI: (01)00827002059795(17)220729(10)9890936

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 16 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0436-2020

Recall number: Z-0436-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 250

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-JB1 REF (GPN): G05997 Lot Numbers: 9712995, 9726996, NS9700766 UDIs: (01)00827002059979(17)220516(10)9712995, (01)00827002059979(17)220516(10)9726996, (01)00827002059979(17)220508(10)NS9700766

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 17 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0437-2020

Recall number: Z-0437-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 951

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-H1 REF (GPN): G06005 Lot Numbers: 9698823, 9702704, 9702705, 9702778, 9702809, 9703680, 9707588, 9714540, 9715463, 9716515, 9716516, 9716517, 9719485 UDIs: (01)00827002060050(17)220508(10)9698823, (01)00827002060050(17)220510(10)9702704, (01)00827002060050(17)220510(10)9702705, (01)00827002060050(17)220513(10)9702778, (01)00827002060050(17)220509(10)9702809, (01)00827002060050(17)220510(10)9703680, (01)00827002060050(17)220509(10)9707588, (01)00827002060050(17)220509(10)9714540, (01)00827002060050(17)220516(10)9715463, (01)00827002060050(17)220510(10)9716515, (01)00827002060050(17)220510(10)9716516, (01)00827002060050(17)220509(10)9716517, (01)00827002060050(17)220514(10)9719485

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 18 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0438-2020

Recall number: Z-0438-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 20

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-JIM REF (GPN): G06039 Lot Numbers: NS9715223, NS9718545 UDIs: (01)00827002060395(17)220515(10)NS9715223, (01)00827002060395(17)220516(10)NS9718545

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 19 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0439-2020

Recall number: Z-0439-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 740

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-VERT REF (GPN): G06074 Lot Numbers: 9696580, 9707470, 9707471, 9710400, 9710402, 9710403, 9710404, 9710405, 9734099, NS9710401 UDIs: (01)00827002060746(17)220508(10)9696580, (01)00827002060746(17)220513(10)9707470, (01)00827002060746(17)220514(10)9707471, (01)00827002060746(17)220515(10)9710400, (01)00827002060746(17)220516(10)9710402, (01)00827002060746(17)220515(10)9710403, (01)00827002060746(17)220515(10)9710404, (01)00827002060746(17)220514(10)9710405, (01)00827002060746(17)220524(10)9734099, (01)00827002060746(17)220513(10)NS9710401

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 20 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0440-2020

Recall number: Z-0440-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 25

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-80-P-NS-MIK REF (GPN): G06108 Lot Number: 9903997 UDI: (01)00827002061088(17)220801(10)9903997

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 21 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0441-2020

Recall number: Z-0441-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 425

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-10S-PIG REF (GPN): G06227 Lot Numbers: 9694590, 9700380, 9700381, 9700765, 9703643, 9703644, 9703645, 9703646, 9711281, 9711282 UDIs: (01)00827002062276(17)220508(10)9694590, (01)00827002062276(17)220510(10)9700380, (01)00827002062276(17)220508(10)9700381, (01)00827002062276(17)220509(10)9700765, (01)00827002062276(17)220513(10)9703643, (01)00827002062276(17)220513(10)9703644, (01)00827002062276(17)220510(10)9703645, (01)00827002062276(17)220510(10)9703646, (01)00827002062276(17)220515(10)9711281, (01)00827002062276(17)220516(10)9711282

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 22 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0442-2020

Recall number: Z-0442-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 60

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-65-P-2S-C2 REF (GPN): G06236 Lot Number: 9914963 UDI: (01)00827002062368(17)220806(10)9914963

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 23 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0443-2020

Recall number: Z-0443-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 16

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-35-80-P-NS-MPB REF (GPN): G06282 Lot Numbers: NS9904055, NS9913496, NS9928938, NS9930289, NS9930290, NS9930291 UDIs: (01)00827002062825(17)220731(10)NS9904055, (01)00827002062825(17)220805(10)NS9913496, (01)00827002062825(17)220812(10)NS9928938, (01)00827002062825(17)220809(10)NS9930289, (01)00827002062825(17)220809(10)NS9930290, (01)00827002062825(17)220812(10)NS9930291

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 24 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0444-2020

Recall number: Z-0444-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 20

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-65-P-NS-H1 REF (GPN): G06607 Lot Numbers: NS9904021, NS9913224, NS9945395 UDIs: (01)00827002066076(17)220801(10)NS9904021, (01)00827002066076(17)220802(10)NS9913224, (01)00827002066076(17)220823(10)NS9945395

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 25 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0445-2020

Recall number: Z-0445-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-35-80-P-2S-C2 REF (GPN): G06622 Lot Numbers: NS9913495, NS9930288 UDIs: (01)00827002066229(17)220805(10)NS9913495, (01)00827002066229(17)220812(10)NS9930288

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 26 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0446-2020

Recall number: Z-0446-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-65-P-2S-C1 REF (GPN): G06827 Lot Number: NS9906241 UDI: (01)00827002068278(17)220801(10)NS9906241

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 27 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0447-2020

Recall number: Z-0447-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 85

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-WNBG REF (GPN): G07099 Lot Number: 9716520 UDI: (01)00827002070998(17)220517(10)9716520

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 28 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0448-2020

Recall number: Z-0448-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 311

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-10S-0 REF (GPN): G07268 Lot Numbers: 9693491, 9696896, 9700377, 9700378, 9700379, 9710398, 9716496, NS9712994 UDIs: (01)00827002072688(17)220508(10)9693491, (01)00827002072688(17)220508(10)9696896, (01)00827002072688(17)220508(10)9700377, (01)00827002072688(17)220509(10)9700378, (01)00827002072688(17)220510(10)9700379, (01)00827002072688(17)220515(10)9710398, (01)00827002072688(17)220517(10)9716496, (01)00827002072688(17)220516(10)NS9712994

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 29 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0449-2020

Recall number: Z-0449-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 98

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-HN5 REF (GPN): G07300 Lot Numbers: NS9700775, NS9705496, NS9710350, NS9713694 UDIs: (01)00827002073005(17)220511(10)NS9700775, (01)00827002073005(17)220509(10)NS9705496, (01)00827002073005(17)220515(10)NS9710350, (01)00827002073005(17)220514(10)NS9713694

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 30 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0450-2020

Recall number: Z-0450-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 35

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-HN4 REF (GPN): G07940 Lot Numbers: NS9708134, NS9708135, NS9713695 UDIs: (01)00827002079403(17)220517(10)NS9708134, (01)00827002079403(17)220516(10)NS9708135, (01)00827002079403(17)220516(10)NS9713695

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 31 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0451-2020

Recall number: Z-0451-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 470

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-MPA REF (GPN): G08153 Lot Numbers: 9696901, 9700384, 9701377, 9708543, 9709229 UDIs: (01)00827002081536(17)220508(10)9696901, (01)00827002081536(17)220513(10)9700384, (01)00827002081536(17)220509(10)9701377, (01)00827002081536(17)220514(10)9708543, (01)00827002081536(17)220509(10)9709229

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 32 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0452-2020

Recall number: Z-0452-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 145

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-35-100-P-10S-PIG REF (GPN): G08201 Lot Numbers: 9700004, 9703928, NS9703929 UDIs: (01)00827002082014(17)220511(10)9700004, (01)00827002082014(17)220510(10)9703928, (01)00827002082014(17)220508(10)NS9703929

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 33 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0453-2020

Recall number: Z-0453-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 265

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB7.0-38-100-P-NS-MPA REF (GPN): G08591 Lot Numbers: 9713048, 9718539, NS9718416 UDIs: (01)00827002085916(17)220515(10)9713048, (01)00827002085916(17)220517(10)9718539, (01)00827002085916(17)220516(10)NS9718416

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 34 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0454-2020

Recall number: Z-0454-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-MPB REF (GPN): G08878 Lot Number: NS9713000 UDI: (01)00827002088788(17)220515(10)NS9713000

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 35 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0455-2020

Recall number: Z-0455-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 1,679

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-DAV REF (GPN): G08895 Lot Numbers: 9693495, 9701375, 9703638, 9703647, 9703648, 9708138, 9708139, 9708140, 9708542, 9709228, 9709932, 9712996, 9715458, 9715462, 9715468, 9715469, 9716505, 9733722, 9734096 UDIs: (01)00827002088955(17)220508(10)9693495, (01)00827002088955(17)220510(10)9701375, (01)00827002088955(17)220510(10)9703638, (01)00827002088955(17)220510(10)9703647, (01)00827002088955(17)220510(10)9703648, (01)00827002088955(17)220513(10)9708138, (01)00827002088955(17)220514(10)9708139, (01)00827002088955(17)220514(10)9708140, (01)00827002088955(17)220513(10)9708542, (01)00827002088955(17)220516(10)9709228, (01)00827002088955(17)220514(10)9709932, (01)00827002088955(17)220516(10)9712996, (01)00827002088955(17)220516(10)9715458, (01)00827002088955(17)220517(10)9715462, (01)00827002088955(17)220516(10)9715468, (01)00827002088955(17)220517(10)9715469, (01)00827002088955(17)220517(10)9716505, (01)00827002088955(17)220524(10)9733722, (01)00827002088955(17)220523(10)9734096

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 36 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0456-2020

Recall number: Z-0456-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-80-P-NS-JR2.5 REF (GPN): G08985 Lot Number: NS9906245 UDI: (01)00827002089853(17)220801(10)NS9906245

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 37 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0457-2020

Recall number: Z-0457-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 20

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-80-P-NS-C3 REF (GPN): G09521 Lot Numbers: 9926069, NS9926068 UDIs: (01)00827002095212(17)220822(10)9926069, (01)00827002095212(17)220809(10)NS9926068

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 38 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0458-2020

Recall number: Z-0458-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 25

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-80-P-NS-MPB REF (GPN): G09631 Lot Number: 9936120 UDI: (01)00827002096318(17)220820(10)9936120

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 39 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0459-2020

Recall number: Z-0459-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-JL2 REF (GPN): G09757 Lot Number: 9716495 UDI: (01)00827002097575(17)220517(10)9716495

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 40 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0460-2020

Recall number: Z-0460-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-35-80-P-2S-C1 REF (GPN): G09875 Lot Number: NS9939340 UDI: (01)00827002098756(17)220816(10)NS9939340

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 41 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0461-2020

Recall number: Z-0461-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 95

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-C2 REF (GPN): G10262 Lot Number: 9729997 UDI: (01)00827002102620(17)220516(10)9729997

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 42 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0462-2020

Recall number: Z-0462-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 45

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-NT-80-P-NS-MPA REF (GPN): G10354 Lot Number: 9930261 UDI: (01)00827002103542(17)220812(10)9930261

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 43 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0463-2020

Recall number: Z-0463-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 45

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-80-P-NS-HS2 REF (GPN): G10598 Lot Numbers: NS9904742, NS9906243, NS9906244, NS9914968, NS9914970, NS9928941, NS9943480, NS9943481 UDIs: (01)00827002105980(17)220731(10)NS9904742, (01)00827002105980(17)220731(10)NS9906243, (01)00827002105980(17)220801(10)NS9906244, (01)00827002105980(17)220805(10)NS9914968, (01)00827002105980(17)220805(10)NS9914970, (01)00827002105980(17)220809(10)NS9928941, (01)00827002105980(17)220826(10)NS9943480, (01)00827002105980(17)220822(10)NS9943481

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 44 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0464-2020

Recall number: Z-0464-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 35

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-80-P-NS-HS1 REF (GPN): G10599 Lot Numbers: NS9903072, NS9904741, NS9914967, NS9928940, NS9933626, NS9942737 UDIs: (01)00827002105997(17)220731(10)NS9903072, (01)00827002105997(17)220801(10)NS9904741, (01)00827002105997(17)220805(10)NS9914967, (01)00827002105997(17)220809(10)NS9928940, (01)00827002105997(17)220816(10)NS9933626, (01)00827002105997(17)220826(10)NS9942737

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 45 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0465-2020

Recall number: Z-0465-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 33

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-JL5 REF (GPN): G10661 Lot Number: 9700389 UDI: (01)00827002106611(17)220508(10)9700389

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 46 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0466-2020

Recall number: Z-0466-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 25

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-JR5 REF (GPN): G10727 Lot Number: 9718544 UDI: (01)00827002107274(17)220516(10)9718544

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 47 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0467-2020

Recall number: Z-0467-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-80-P-NS-JR2 REF (GPN): G10733 Lot Numbers: NS9906320, NS9906321 UDIs: (01)00827002107335(17)220731(10)NS9906320, (01)00827002107335(17)220801(10)NS9906321

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 48 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0468-2020

Recall number: Z-0468-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 232

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-110-P-12S-PIG REF (GPN): G10741 Lot Numbers: 9706696, 9707671, 9709328, 9711384, 9718538 UDIs: (01)00827002107410(17)220513(10)9706696, (01)00827002107410(17)220514(10)9707671, (01)00827002107410(17)220515(10)9709328, (01)00827002107410(17)220515(10)9711384, (01)00827002107410(17)220516(10)9718538

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 49 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0469-2020

Recall number: Z-0469-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-80-P-NS-JL2.5 REF (GPN): G10742 Lot Number: NS9933622 UDI: (01)00827002107427(17)220812(10)NS9933622

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 50 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0470-2020

Recall number: Z-0470-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 30

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-AR2 REF (GPN): G10748 Lot Number: 9714133 UDI: (01)00827002107489(17)220516(10)9714133

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 51 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0471-2020

Recall number: Z-0471-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-AL2 REF (GPN): G10750 Lot Number: 9710345 UDI: (01)00827002107502(17)220515(10)9710345

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 52 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0472-2020

Recall number: Z-0472-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-AR1 REF (GPN): G10751 Lot Number: 9707476 UDI: (01)00827002107519(17)220514(10)9707476

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 53 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0473-2020

Recall number: Z-0473-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 95

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-VTK REF (GPN): G10756 Lot Number: 9712522 UDI: (01)00827002107564(17)220516(10)9712522

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 54 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0474-2020

Recall number: Z-0474-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-80-P-NS-EKISAI-111984 REF (GPN): G10796 Lot Number: NS9904740 UDI: (01)00827002107960(17)220801(10)NS9904740

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 55 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0475-2020

Recall number: Z-0475-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-80-P-NS-RIM REF (GPN): G10885 Lot Number: NS9939355 UDI: (01)00827002108851(17)220820(10)NS9939355

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 56 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0476-2020

Recall number: Z-0476-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-JR2 REF (GPN): G10924 Lot Numbers: NS9712997, NS9712998 UDIs: (01)00827002109247(17)220516(10)NS9712997, (01)00827002109247(17)220515(10)NS9712998

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 57 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0477-2020

Recall number: Z-0477-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 135

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-JR3 REF (GPN): G10930 Lot Numbers: 9714956, 9719147 UDIs: (01)00827002109308(17)220516(10)9714956, (01)00827002109308(17)220513(10)9719147

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 58 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0478-2020

Recall number: Z-0478-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 195

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-NS-JL3 REF (GPN): G10998 Lot Numbers: 9712521, 9732872, NS9717350 UDIs: (01)00827002109988(17)220516(10)9712521, (01)00827002109988(17)220517(10)9732872, (01)00827002109988(17)220517(10)NS9717350

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 59 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0479-2020

Recall number: Z-0479-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 30

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-35-100-P-8S-NEFF REF (GPN): G11026 Lot Number: NS9720276 UDI: (01)00827002110267(17)220516(10)NS9720276

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 60 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0480-2020

Recall number: Z-0480-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 30

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-80-P-NS-RC1 REF (GPN): G11543 Lot Number: 9906464 UDI: (01)00827002115439(17)220801(10)9906464

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 61 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0481-2020

Recall number: Z-0481-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-100-P-4S-NIH REF (GPN): G11749 Lot Numbers: 9700773, 9705822 UDIs: (01)00827002117495(17)220509(10)9700773, (01)00827002117495(17)220513(10)9705822

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 62 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0482-2020

Recall number: Z-0482-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB4.1-35-80-P-NS-NTR REF (GPN): G12517 Lot Number: NS9930287 UDI: (01)00827002125179(17)220812(10)NS9930287

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 63 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0483-2020

Recall number: Z-0483-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-65-P-1S-VA-070793 REF (GPN): G12783 Lot Number: NS9933578 UDI: (01)00827002127838(17)220812(10)NS9933578

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 64 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0484-2020

Recall number: Z-0484-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 100

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-110-P-12S-PED REF (GPN): G13077 Lot Numbers: 9700036, 9707670 UDIs: (01)00827002130777(17)220509(10)9700036, (01)00827002130777(17)220515(10)9707670

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 65 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0485-2020

Recall number: Z-0485-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 35

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-35-65-P-NS-TIPS REF (GPN): G19706 Lot Number: 9890919 UDI: (01)00827002197060(17)220729(10)9890919

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 66 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0486-2020

Recall number: Z-0486-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-35-100-P-NS-JR2 REF (GPN): G27617 Lot Number: NS9705494 UDI: (01)00827002276178(17)220510(10)NS9705494

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 67 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0487-2020

Recall number: Z-0487-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-35-75-P-NS-CHG-B REF (GPN): G27640 Lot Number: NS9913494 UDI: (01)00827002276406(17)220805(10)NS9913494

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 68 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0488-2020

Recall number: Z-0488-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-70-P-NS-SHK1.0 REF (GPN): G27689 Lot Number: NS9904739 UDI: (01)00827002276895(17)220801(10)NS9904739

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 69 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0489-2020

Recall number: Z-0489-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-75-P-NS-C1 REF (GPN): G27702 Lot Number: NS9928939 UDI: (01)00827002277021(17)220809(10)NS9928939

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 70 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0490-2020

Recall number: Z-0490-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB5.0-38-80-P-NS-JR1.5 REF (GPN): G30163 Lot Number: NS9933623 UDI: (01)00827002301634(17)220816(10)NS9933623

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

device · product 71 of 71

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Z-0491-2020

Recall number: Z-0491-2020
Initiated: October 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 230

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Code information

REF (RPN): HNB6.0-38-65-P-NS-BMC REF (GPN): G32465 Lot Numbers: 9908469, 9911359, 9936124 UDIs: (01)00827002324657(17)220805(10)9908469, (01)00827002324657(17)220805(10)9911359, (01)00827002324657(17)220821(10)9936124

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

Event summary

Source snapshots represented here

Every recalled product in this event

Reason for recall

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