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Recall Observatory FDA recall evidence

Device product

PROTEXIS Latex Micro Surgical Gloves Size 8.0 - 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.

Z-2917-2020

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-2917-2020

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: 2D72NT80X Lot #: TS19060095, TS19060169, TS19060328, TS19060357, TS19070100, TS19080183, TS19080225, TS19080308, TS19090043, TS19090188, TS19090292, TS19100150, TS19100214, TS19100282, TS19110050, TS19110115, TS19110295, TS19110334, TS19120049, TS20050165 Additional Affected Lots as of 10/20/20: TS20040334, TS20040358, TS20040359, TS20050106, TS20050322, TS20060026, TS20060084

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.