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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81579

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

Open FDA event record

Event summary

Timeline bucket
October 31, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cardinal Health 200, LLC

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

8 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 8

Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Z-0631-2019
Recall number
Z-0631-2019
Initiated
October 31, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
1,475,095 pairs total

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label in error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.

Code information

Product code: 2D73DP55, Lot Numbers: TS18060249, TS18070244, TS18080021, TS18080344, and TS18090280.

Distribution pattern

Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and to countries of: Austria, Belgium, Canada, Chile, Costa Rica, France, Germany, Italy, Luxembourg, Martinique, Monaco, Netherlands, Poland, Reunion, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.

device · product 2 of 8

Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Z-0632-2019
Recall number
Z-0632-2019
Initiated
October 31, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
1,475,095 pairs total

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label in error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.

Code information

Product code: 2D73DP60, Lot Numbers: TS18060125, TS18060250, TS18060328, TS18070031, TS18070245, TS18070392, TS18080025, TS18080345, TS18080444, TS18090119, and TS18090281

Distribution pattern

Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and to countries of: Austria, Belgium, Canada, Chile, Costa Rica, France, Germany, Italy, Luxembourg, Martinique, Monaco, Netherlands, Poland, Reunion, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.

device · product 3 of 8

Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Z-0633-2019
Recall number
Z-0633-2019
Initiated
October 31, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
1,475,095 pairs total

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label in error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.

Code information

Product code: 2D73DP65, Lot Numbers: TS18050409, TS18060149, TS18060240, TS18060312, TS18070036, TS18070106, TS18070306, TS18070371, TS18080026, TS18080348, TS18080445, TS18090113, TS18090159, TS18090212, and TS18090282.

Distribution pattern

Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and to countries of: Austria, Belgium, Canada, Chile, Costa Rica, France, Germany, Italy, Luxembourg, Martinique, Monaco, Netherlands, Poland, Reunion, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.

device · product 4 of 8

Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Z-0634-2019
Recall number
Z-0634-2019
Initiated
October 31, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
1,475,095 pairs total

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label in error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.

Code information

Product code:, 2D73DP70, Lot Numbers: TS18050417, TS18060144, TS18060234, TS18060314, TS18070120, TS18070307, TS18070379, TS18080022, TS18080349, TS18080446, TS18090120, TS18090155, TS18090211, and TS18090288.

Distribution pattern

Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and to countries of: Austria, Belgium, Canada, Chile, Costa Rica, France, Germany, Italy, Luxembourg, Martinique, Monaco, Netherlands, Poland, Reunion, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.

device · product 5 of 8

Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Z-0635-2019
Recall number
Z-0635-2019
Initiated
October 31, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
1,475,095 pairs total

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label in error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.

Code information

Product code: 2D73DP75, Lot Numbers: TS18060009, TS18060145, TS18060251, TS18060322, TS18070037, TS18070122, TS18070312, TS18070380, TS18080033, TS18080350, TS18090125, TS18090154, TS18090213, and TS18090290.

Distribution pattern

Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and to countries of: Austria, Belgium, Canada, Chile, Costa Rica, France, Germany, Italy, Luxembourg, Martinique, Monaco, Netherlands, Poland, Reunion, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.

device · product 6 of 8

Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Z-0636-2019
Recall number
Z-0636-2019
Initiated
October 31, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
1,475,095 pairs total

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label in error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.

Code information

Product code: 2D73DP80, Lot Numbers: TS18060134, TS18060230, TS18060323, TS18070039, TS18070313, TS18070372, TS18080027, TS18080351, TS18090164, TS18090218, and TS18090289.

Distribution pattern

Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and to countries of: Austria, Belgium, Canada, Chile, Costa Rica, France, Germany, Italy, Luxembourg, Martinique, Monaco, Netherlands, Poland, Reunion, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.

device · product 7 of 8

Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Z-0637-2019
Recall number
Z-0637-2019
Initiated
October 31, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
1,475,095 pairs total

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label in error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.

Code information

Product code: 2D73DP85, Lot Numbers: TS18060015, TS18060329, TS18070121, TS18070314, TS18080034, TS18080352, and TS18090219.

Distribution pattern

Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and to countries of: Austria, Belgium, Canada, Chile, Costa Rica, France, Germany, Italy, Luxembourg, Martinique, Monaco, Netherlands, Poland, Reunion, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.

device · product 8 of 8

Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Z-0638-2019
Recall number
Z-0638-2019
Initiated
October 31, 2018
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
1,475,095 pairs total

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label in error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.

Code information

Product code: 2D73DP90, Lot Numbers: TS18060016, TS18070126, TS18070315, TS18080353, and TS18090220.

Distribution pattern

Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and to countries of: Austria, Belgium, Canada, Chile, Costa Rica, France, Germany, Italy, Luxembourg, Martinique, Monaco, Netherlands, Poland, Reunion, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.