Z-2914-2020 Class II
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2020
- Initiation Date
- July 29, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7119625 total
Product Description
PROTEXIS Latex Micro Surgical Gloves Size 6.5 - 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.
Reason for Recall
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
Distribution Pattern
US Nationwide distribution
Code Information
Item Code: 2D72NT65X Lot #: TS19060064, TS19060158, TS19060303, TS19060393, TS19070019, TS19070068, TS19070138, TS19070185, TS19070297, TS19080022, TS19080051, TS19080128, TS19080134, TS19080239, TS19080326, TS19090058, TS19090104, TS19090212, TS19090295, TS19100043, TS19100138, TS19100173, TS19100310, TS19110023, TS19110083, TS19110150, TS19110211, TS19110349, TS20020024, TS20020262, TS20030066, TS20030179, TS20030219, TS20030318, TS20040116 Additional Affected Lots as of 10/20/20: TS20040111, TS20040069, TS20040104, TS20040174, TS20040293, TS20050140, TS20050181, TS20050182, TS20050268, TS20050269, TS20050336, TS20050344, TS20050378, TS20060010,TS20060064, TS20060065, TS20060138, TS20060140, TS20060224, TS20060225, TS20060285, TS20060286, TS20070003, TS20070081 Additional Affected Lots as of 2/23/21: TS20070179