Z-2919-2020 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 9.0 - 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: 2D72NT90X Lot #: TS19080275, TS19090162, TS19090231, TS20010216, TS20030153 Additional Affected Lots of as 10/20/20: TS20040290, TS20050032, TS20060107 Additional Affected Lots as of 2/23/21: TS20040344