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Recall Observatory FDA recall evidence

Device product

BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.

Z-2378-2018

January 12, 2018

Class II

Product summary

Firm
Medline Industries, Inc.
Event
Event 80197
Status
Terminated
Classification
Class II
Quantity
6/5-kit cases
Official record key
device-enforcement:Z-2378-2018

Official wording

Reason: One of the cases of product might not have been sterilized.

Code information: Lot 17YM5936, Exp. 04/30/2019

Distribution pattern: The product was distributed to UT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One of the cases of product might not have been sterilized.