Reported Dec 26, 2018 · Terminated
Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile light brown colored surgeons gloves…
Cardinal Health 200, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health 200, LLC · 3651 Birchwood Dr · Waukegan, IL · 60085-8337
Is this the product you have?
- 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.
- Lot codes and dates
- Product code2D73DP65
- Lot Numbers
TS18050409TS18060149TS18060240TS18060312TS18070036TS18070106TS18070306TS18070371TS18080026TS18080348TS18080445TS18090113TS18090159TS18090212and TS18090282
- Amount recalled
- 1,475,095 pairs total
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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