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Recall Observatory FDA recall evidence

Device product

PROTEXIS Latex Micro Surgical Gloves Size 6.5 - 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-2914-2020

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-2914-2020

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: 2D72NT65X Lot #: TS19060064, TS19060158, TS19060303, TS19060393, TS19070019, TS19070068, TS19070138, TS19070185, TS19070297, TS19080022, TS19080051, TS19080128, TS19080134, TS19080239, TS19080326, TS19090058, TS19090104, TS19090212, TS19090295, TS19100043, TS19100138, TS19100173, TS19100310, TS19110023, TS19110083, TS19110150, TS19110211, TS19110349, TS20020024, TS20020262, TS20030066, TS20030179, TS20030219, TS20030318, TS20040116 Additional Affected Lots as of 10/20/20: TS20040111, TS20040069, TS20040104, TS20040174, TS20040293, TS20050140, TS20050181, TS20050182, TS20050268, TS20050269, TS20050336, TS20050344, TS20050378, TS20060010,TS20060064, TS20060065, TS20060138, TS20060140, TS20060224, TS20060225, TS20060285, TS20060286, TS20070003, TS20070081 Additional Affected Lots as of 2/23/21: TS20070179

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.