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Recall Observatory FDA recall evidence

Device product

Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healthcare workers and/or consumers.

Z-2828-2018

July 02, 2018

Class II

Product summary

Firm
Cypress Medical Products LLC
Event
Event 80669
Status
Terminated
Classification
Class II
Quantity
66 cases
Official record key
device-enforcement:Z-2828-2018

Official wording

Reason: The firm is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because a sample of product from that lot did not meet certain release specifications. It is possible that certain gloves from this lot may not be of medical exam quality and, therefore, may not provide an effective barrier to infectious material.

Code information: CDZG09-30

Distribution pattern: US Nationwide Distribution in the states of in AL, AR, IA, LA, OK, TX, UT, and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because a sample of product from that lot did not meet certain release specifications. It is possible that certain gloves from this lot may not be of medical exam quality and, therefore, may not provide an effective barrier to infectious material.