Recall Z-2378-2018— Medline Industries, Inc.

Name: FDA recall Z-2378-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-12

Class II · Terminated

Class II FDA medical device recall by Medline Industries, Inc., initiated 2018-01-12, terminated 2020-07-22. FDA's recall record names no specific 510(k) clearance for this event. Product: BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.. Reason: One of the cases of product might not have been sterilized..

Recalling firm: Medline Industries, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-01-12
Terminated: 2020-07-22
Firm location: Waukegan, IL, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.