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Recall Observatory FDA recall evidence

Device product

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

Z-0741-2017

October 12, 2016

Class II

Product summary

Firm
CYPRESS MEDICAL PRODUCTS
Event
Event 75638
Status
Terminated
Classification
Class II
Quantity
2005.2 cases have been distributed
Official record key
device-enforcement:Z-0741-2017

Official wording

Reason: A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.

Code information: Lot Number: CDZF06-03

Distribution pattern: US Distribution. This recall is limited to one distribution center in Auburn, Washington, and the customers serviced from that distribution center.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.