Z-0637-2019Class II

Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a...

Name: Z-0637-2019 Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a...
Creator: Cardinal Health 200, LLC
Published: 2018-10-31
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-10-31 / Terminated / root cause: labeling and UDI

FDA source

Cardinal Health 200, LLC began a recall of Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber... on 2018-10-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0637-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-31
Posted: 2018-12-19
Terminated: 2025-08-12
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: KGO Surgeon'S Gloves
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Cardinal Health notified customers on about 10/31/2018 via "URGENT: PRODUCT CORRECTION NOTICE." Customers were instructed to examine inventory for affected products, affix the provided warning label on the principal display panel on the affected dispenser packs, notify internal parties and/or customers if the product was further distributed of the recall, and complete and return the provided Acknowledgement Form. If the wallets containing the gloves are removed from the dispenser packs, customers were also instructed to provide a warning label to accompany the affected product inform users of the correct breakthrough times. If customers need additional labels, they were instructed to contact 800-292-9332 or [email protected] for assistance. For further questions regarding the Product Correction Notice, please reference the following Customer Service telephone numbers: Hospital (800-964-5227), Federal Government (800-444-1166), Distributor (800-635-6021), All other customers (888-444-5440).
Quantity in commerce: 1,475,095 pairs total
Distribution: 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.
Product codes and lots: Product code: 2D73DP85, Lot Numbers: TS18060015, TS18060329, TS18070121, TS18070314, TS18080034, TS18080352, and TS18090219.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0637-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0631-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18
Z-0632-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18
Z-0633-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18
Z-0634-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18
Z-0635-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18
Z-0636-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18
Z-0637-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18
Z-0638-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-18

Product code KGO

K113707Class ISterile Neoprene Powder-Free Surgical Gloves with Nitrile CoatingCardinal Health-Medical Products and Services / cleared 2012-04-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)