PROTEXIS Latex Micro Surgical Gloves Size 7.0 - 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.
Enforcement
- Recall Number
- Z-2915-2020
- Event ID
- 86131
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Cardinal Health 200, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 9, 2020
- Initiation Date
- July 29, 2020
- Classification Date
- August 28, 2020
- Address
- 3651 Birchwood Dr, N/A, Waukegan, IL, 60085-8337, United States
Description
PROTEXIS Latex Micro Surgical Gloves Size 7.0 - 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.
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
Item Code: 2D72NT70X Lot #: TS19060339, TS19070029, TS19070108, TS19070180, TS19070285, TS19080035, TS19080064, TS19080140, TS19080186, TS19080271, TS19090054, TS19090149, TS19090266, TS19100058, TS19100107, TS19100186, TS19100308, TS19110038, TS19110090, TS19110157, TS19110225, TS19120005, TS20030299, TS20040046 Additional Affected Lots as of 10/20/20: TS20040204, TS20040260, TS20040312, TS20050113, TS20050157, TS20050289, TS20050290, TS20050391, TS20060093, TS20060152, TS20060153, TS20060204, TS20060237, TS20060238, TS20060296, TS20060304, TS20060305, TS20070020, TS20070107
US Nationwide distribution
7119625 total