Medical device recalls Moderate risk

Cypress Medical Products LLC recalls Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healt…

Recall date
July 2, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2828-2018
FDA classification
Class II
Brand / firm
Cypress Medical Products LLC
Sold / distributed
US Nationwide Distribution in the states of in AL, AR, IA, LA, OK, TX, UT, and VA.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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