PROTEXIS Latex Micro Surgical Gloves Size 6.0 - 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-2913-2020
- 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 6.0 - 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: 2D72NT60X Lot #: TS19060043, TS19060123, TS19060199, TS19070005, TS19070027, TS19070067, TS19070130, TS19070179, TS19070273, TS19080030, TS19090067, TS19090158, TS19090226, TS19090289, TS19110333, TS19120019, TS19120322, TS20020121, TS20030015, TS20030324 Additional Affected Lots as of 10/20/20: TS20040173, TS20040249, TS20040257, TS20040333, TS20050052, TS20050069, TS20050152, TS20050153, TS20050196, TS20050197, TS20050334, TS20050335, TS20060011, TS20060053, TS20060054, TS20060115, TS20060116, TS20060199, TS20060200, TS20060250, TS20070023, TS20070108, TS20070183
US Nationwide distribution
7119625 total