Z-2918-2020 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 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.
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: 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