Atlas FDA

McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140

FDA device recall Z-0741-2017 · posted 2016-12-12 · Terminated

Recall details

Recalling firm
CYPRESS MEDICAL PRODUCTS
Reason for recall
A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.
Action taken
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
Status
Terminated
Product code
LYZ
Quantity affected
2005.2 cases have been distributed
Distribution
US Distribution. This recall is limited to one distribution center in Auburn, Washington, and the customers serviced from that distribution center.
Date initiated
2016-10-12
Date posted
2016-12-12
Date terminated
2017-03-27
Location
Richmond, VA

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Related 510(k) clearances

RecordFirmDate
POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) (K120968)Tangshan Zhonghong Pulin Plastic Co.,Ltd2012-09-19