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Recall Observatory FDA recall evidence

Device product

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.

Z-2918-2020

July 29, 2020

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 86131
Status
Completed
Classification
Class II
Quantity
7119625 total
Official record key
device-enforcement:Z-2918-2020

Official wording

Reason: A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

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

Distribution pattern: US Nationwide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.