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U.S. Department of Health and Human Services

Class 2 Device Recall McKesson Powder Free Vinyl Exam Gloves

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 Class 2 Device Recall McKesson Powder Free Vinyl Exam Glovessee related information
Date Initiated by FirmOctober 12, 2016
Date PostedDecember 12, 2016
Recall Status1 Terminated 3 on March 27, 2017
Recall NumberZ-0741-2017
Recall Event ID 75638
510(K)NumberK120968 
Product Classification Vinyl patient examination glove - Product Code LYZ
ProductMcKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140
Code Information Lot Number: CDZF06-03
FEI Number 1451040
Recalling Firm/
Manufacturer		 CYPRESS MEDICAL PRODUCTS
9954 Mayland Dr Ste 4000
Richmond VA 23233-1464
Manufacturer Reason
for Recall		A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.
FDA Determined
Cause 2		Process control
ActionA 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 Commerce2005.2 cases have been distributed
DistributionUS Distribution. This recall is limited to one distribution center in Auburn, Washington, and the customers serviced from that distribution center.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LYZ
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