Z-2917-2020 Class II
FDA device recall Z-2917-2020 was initiated by Cardinal Health 200, LLC on July 29, 2020 and is designated Class II. Reason for recall: A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. Affected quantity: 7119625 total.
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 8.0 - 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: 2D72NT80X Lot #: TS19060095, TS19060169, TS19060328, TS19060357, TS19070100, TS19080183, TS19080225, TS19080308, TS19090043, TS19090188, TS19090292, TS19100150, TS19100214, TS19100282, TS19110050, TS19110115, TS19110295, TS19110334, TS19120049, TS20050165 Additional Affected Lots as of 10/20/20: TS20040334, TS20040358, TS20040359, TS20050106, TS20050322, TS20060026, TS20060084