McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140
FDA Recall Z-0741-2017 · Posted 2016-12-12
Recalling FirmCYPRESS MEDICAL PRODUCTS
Recall StatusTerminated
Product CodeLYZ
Date Initiated2016-10-12
Date Terminated2017-03-27
Product Quantity2005.2 cases have been distributed
Reason for Recall
A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.
Firm Action
A letter, dated October 19, 2016, on Cypress Medical Products letterhead, was sent to customers.
Customers were requested to stop use and quarantine the gloves.
Root Cause
Process control
Distribution Pattern
US Distribution. This recall is limited to one distribution center in Auburn, Washington, and the customers serviced from that distribution center.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.