FDA recall Z-2828-2018

Cypress Medical Products LLC · Class II · 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.

Reason for recall

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-07-02
Report date
2018-08-22
Termination date
2023-04-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2828-2018