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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79512

14 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 22, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Arrow International Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

14 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 14

(1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A

Z-1323-2018
Recall number
Z-1323-2018
Initiated
December 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information

(1) Lot Number: 13F17D0179; (2) Lot Numbers: 13F17B0232, 13F17C0357, 13F17D0312, 13F17E0289, 13F17F0154, 13F17F0327, 13F17F0614

Distribution pattern

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

device · product 2 of 14

(1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21242-UCD; (4) ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit, Product Number: CDC-21242-1A; (5) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29803-1A; (6) ARROWg+ard Blue¿ PSI Kit, Product Number: CDC-29903-1A

Z-1324-2018
Recall number
Z-1324-2018
Initiated
December 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information

Lot Numbers: (1) 13F16L0254, 13F17B0196, 13F17C0046; (2) 13F17D0212, 13F17E0770, 13F17F0438; (3) 13F17E0656, 13F17F0188, 13F17F0459; (4) 13F17B0139, 13F17B0140, 13F17B0141, 13F17B0142, 13F17D0131, 13F17D0141, 13F17E0509, 13F17E0510, 13F17E0867, 13F17F0439; (5) 13F17C0339, 13F17E0230, 13F17E0718; (6) 13F16L0179, 13F17E0042, 13F17E0231, 13F17E0411, 13F17E0836

Distribution pattern

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

device · product 3 of 14

Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB

Z-1325-2018
Recall number
Z-1325-2018
Initiated
December 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information

Lot Number: 13F17B0123

Distribution pattern

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

device · product 4 of 14

AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A; (5) CA-42854-P1A; (6) CA-45703-P1A; AGB+ Pressure Injectable Quad-Lumen CVC Kit (7) CA-45854-P1A; (8) CDA-42703-P1A; AGB+ Quad-Lumen CVC Kit (9) AK-42854-P1A; (10) AK-45854-P1A; AGB+ Two Lumen CVC Kit (11) AK-42802-P1A; (12) AK-45802-P1A; (13) AK-46702-P1A; (14) AK-47702-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Multi-Lumen CVC Kit (15) CDA-45703-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Quad-Lumen CVC Kit (16) CDA-45854-P1A; ARROWg+ard BLUE PLUS Pressure Injectable Two-Lumen CVC Kit (17) CDA-22122-U1A; (18) CDA-42802-P1A; (19) CDA-42854-P1A; (20) CDA-47702-P1A; ARROWg+ard Blue¿ MAC" Two-Lumen CVC Access Kit (21) CDA-21242-1A; ARROWg+ard Blue¿ PSI Kit (22) CDA-29803-1A; ARROWg+ard Blue¿ Two-Lumen CVC Kit (23) AK-22702-P1A; ARROWg+ard Blue¿ You-Bend" Two- Lumen Hemodialysis Catheterization Kit for High Volume Infusions (24) CDA-25122-U1A; Multi-Lumen CVC Kit with Blue FlexTip(R) Catheter and Sharps Safety Features (25) ASK-12703-PRJ; (26) ASK-15703-PRJ; Multi-Lumen Pressure Injectable Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features (27) ASK-45703-PRH; Pressure Injectable ARROWg+ard Blue Plus(R) Multi-Lumen CVC Kit (28) ASK-45703-PRWJ1; Pressure Injectable ARROWg+ard Blue PLUS(R) Quad-Lumen CVC Kit (29) ASK-42854-PRJ; Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central CVC Kit (30) ASK-47702-PPHP; Pressure Injectable ARROWg+ard Blue PLUS(R)Multi-Lumen CVC Kit (31) ASK-45703-PUCD; Pressure Injectable Multi-Lumen CVC Kit (32) ASK-12703-PCA; (33) ASK-15703-PCA; (34) ASK-15703-PHH; (35) ASK-15703-PLV; Pressure Injectable Multi-Lumen CVC kit with Blue Flex Tip¿, ARROWg+ard Blue PLUS¿ Catheter and Sharps Safety Features (36) ASK-42703-PBM; (37) ASK-15703-PRH; (38) ASK-15703-PRWJ; (39) ASK-42703-PRJ; (40) ASK-45703-PRJ; Pressure Injectable Quad-Lumen CVC Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions (41) ASK-42854-PNMM; Pressure Injectable Two Lumen CVC Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features (42) ASK-42802-PBM

Z-1326-2018
Recall number
Z-1326-2018
Initiated
December 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information

Lot Numbers: (1) 13F17A0135, 13F17C0355, 13F17E0212, 13F17E0789, 13F17F0386; (2) 13F17A0028, 13F17E0044, 13F17E0448; (3) 13F17B0118, 13F17F0385; (4) 13F17B0152, 13F17C0057; (5) 13F17F0226; (6) 13F17A0157, 13F17B0117, 13F17C0250; (7) 13F17F0071; (8) 13F17A0022, 13F17A0301, 13F17C0266, 13F17D0039; (9) 13F17B0041, 13F17E0764; (10) 13F16M0169, 13F17B0262, 13F17C0468; (11) 13F17D0323, 13F17E0310, 13F17E0467; (12) 13F17B0085, 13F17E0150, 13F17F0345; (13) 13F17E0751; (14) 13F17E0211; (15) 13F17A0167, 13F17B0145, 13F17C0466, 13F17E0095, 13F17F0261; (16) 13F17C0325, 13F17D0283; (17) 13F17E0616, 13F17F0256; (18) 13F17C0318; (19) 13F16M0048, 13F17E0124,13F17F0497; (20) 13F17B0249; (21) 13F17F0437; (22) 13F17C0267, 13F17E0385; (23)13F17D0194, 13F17F0486; (24) 13F16M0184, 13F17E0617; (25) 13F17B0279, 13F17D0112; (26) 13F17B0265; (27) 13F17E0402; (28) 13F17A0067; (29) 13F17E0796; (30) 13F17C0492; (31) 13F17C0140, 13F17D0055, 13F17F0255; (32) 13F17F0240; (33) 13F17F0575; (34) 13F17B0239, 13F17C0300, 13F17D0297, 13F17F0015; (35) 13F17E0390; (36) 13F17B0134, 13F17C0472; (37) 13F17C0279; (38) 13F17B0199, 13F17C0400; (39) 13F17A0296, 13F17D0110, 13F17F0319; (40) 13F16M0019, 13F17B0343, 13F17D0113; (41) 13F17A0172, 13F17B0401, 13F17E0163, 13F17E0631, 13F17F0338; (42) 13F17E0543, 13F17F0208

Distribution pattern

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

device · product 5 of 14

Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4

Z-1327-2018
Recall number
Z-1327-2018
Initiated
December 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information

Lot Numbers: (1) 13F17D0187; (2) 13F17D0222, 13F17E0849

Distribution pattern

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

device · product 6 of 14

Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions, Part Number: CDC-12123-P1A

Z-1328-2018
Recall number
Z-1328-2018
Initiated
December 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information

Lot Number: 13F17F0081

Distribution pattern

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

device · product 7 of 14

(1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09803-WBH1; (2) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-KH; (3) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-LC; (4) PSI Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09903-PHP; (5) Percutaneous Sheath Introducer Kit for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09907-LGH1; (6) Arrow PSI Kit, Part Number: CDC-09803-1A; (7) Arrow PSI Kit, Part Number: CDC-09903-1A

Z-1329-2018
Recall number
Z-1329-2018
Initiated
December 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information

Lot Numbers: (1) 13F17C0208, 13F17F0162; (2) 13F17F0231; (3) 13F17E0382, 13F17F0206; (4) 13F17D0049; (5) 13F17A0052, 13F17C0390; (6) 13F17A0123, 13F17E0014, 13F17E0455, 13F17F0289; (7) 13F16M0274, 13F17E0040, 13F17E0227, 13F17E0824

Distribution pattern

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

device · product 8 of 14

(1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550-UHC; (4) Arterial Catheterization Kit, PN: NA-04550-X1A

Z-1330-2018
Recall number
Z-1330-2018
Initiated
December 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information

Lot Numbers: (1) 13F17D0198, 13F17F0215; (2) 13F17E0029, 13F17E0537; (3) 13F17B0226, 13F17D0017, 13F17D0280; (4) 13F17A0122, 13F17C0342, 13F17E0364, 13F17E0827

Distribution pattern

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

device · product 9 of 14

(1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550-NYP

Z-1331-2018
Recall number
Z-1331-2018
Initiated
December 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information

Lot Numbers: (1) 13F17D0048; (2) 13F17E0659; (3) 13F17A0075, 13F17C0503, 13F17D0296, 13F17E0541, 13F17F0220, 13F17G0002

Distribution pattern

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

device · product 10 of 14

(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A

Z-1332-2018
Recall number
Z-1332-2018
Initiated
December 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information

Lot Numbers: (1) 13F17E0546; (2) 13F16L0177, 13F17E0449, 13F17E0873, 13F17F0295; (3) 13F17E0677, 13F17F0477; (4) 13F17A0318, 13F17F0083; (5) 13F16M0272, 13F17E0648; (6) 13F17B0122, 13F17F0512; (7) 13F17A0320, 13F17F0528

Distribution pattern

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

device · product 11 of 14

ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions, PN: ASK-24301-GM; (5) Hemodialysis Catheterization Kit for High Volume Infusions, PN: CDC-25123-1A

Z-1333-2018
Recall number
Z-1333-2018
Initiated
December 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information

Lot Numbers: (1) 13F17B0345, 13F17E0644, 13F17E0871, 13F17F0291; (2) 13F17B0124, 13F17B0355, 13F17E0727; (3) 13F16M0266, 13F17C0484, 13F17E0798; (4) 13F17B0037, 13F17E0451; (5) 13F17A0017, 13F17A0314, 13F17D0060, 13F17E0799, 13F17F0489

Distribution pattern

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

device · product 12 of 14

Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD

Z-1334-2018
Recall number
Z-1334-2018
Initiated
December 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information

Lot Numbers: (1) 13F17D0188, 13F17E0570; (2) 13F17E0660

Distribution pattern

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

device · product 13 of 14

AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two-Lumen CVC Kit (8) PN: CDC-45802-1A, (9) PN: CDC-45802-B1A, (10) PN: CDC-46702-1A, (11) CDC-47702-1A; (12) Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features, PN: ASK-45703-AH

Z-1335-2018
Recall number
Z-1335-2018
Initiated
December 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information

Lot Numbers: (1) 13F17F0049; (2) 13F17B0224, 13F17E0142, 13F17E0830; (3) 13F16L0220; (4) 13F17E0463, 13F17F0169; (5) 13F17E0685; (6) 13F17D0275, 13F17D0325; (7) 13F17C0470, 13F17D0243; (8) 13F17E0358; (9) 13F17B0031, 13F17E0626; (10) 13F17B0035, 13F17E0627; (11) 13F17B0135, 13F17D0191; (12) 13F16M0173, 13F17C0414

Distribution pattern

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

device · product 14 of 14

ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A

Z-1336-2018
Recall number
Z-1336-2018
Initiated
December 22, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information

Lot Numbers: (1) 13F16M0268, 13F17C0395, 13F17E0158, 13F17E0536; (2) 13F17A0254; (3) 13F16M0233, 13F17D0190; (4) 13F17B0137, 13F17D0225

Distribution pattern

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.