Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0741-2017Class II

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

Cypress Medical Products LLC / initiated 2016-10-12 / Terminated / root cause: manufacturing process

CYPRESS MEDICAL PRODUCTS began a recall of McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140 on . FDA classified it as Class II and gives the reason as "A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0741-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Cypress Medical Products LLC
Product
McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140
Product code
LYZ Vinyl Patient Examination Glove
Reason for recall
A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.
Root cause tag
manufacturing process
FDA root cause
Process control
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.
Quantity in commerce
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.
Product codes and lots
Lot Number: CDZF06-03

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0741-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0741-2017Class IITerminatedVoluntary: Firm initiated