FDAFDA · Food and drugs·Recall number Z-2918-2020
PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.
Published September 9, 2020 · Recall initiated: July 29, 2020
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health 200, LLC
- Distributor
- US Nationwide distribution
- Lot
- Item Code: 2D72NT85X Lot #: TS19060044, TS19060122, TS19060189, TS19080111, TS19080184, TS19080227, TS19090008, TS19090127, TS19100079, TS19100220, TS19110109, TS19110285, TS19110331, TS19120316, TS20050031, TS20050139 Additional Affected Lots as of 10/20/20: TS20050169, TS20050262, TS20060005
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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