Z-2912-2020 Class II
FDA device recall Z-2912-2020 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 5.5 - 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: 2D72NT55X Lot #: TS19060338, TS19070077, TS19070176, TS19090164, TS19090248, TS19100272, TS19110080, TS20010146, TS20020202, TS20040092 Additional Affected lots as of 10/20/20: TS20040247, TS20050050, TS20050051, TS20050261, TS20060112, TS20060113, TS20070125