Recall Z-2378-2018

Medline Industries, Inc. · initiated January 12, 2018

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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

Codes / lots: Lot 17YM5936, Exp. 04/30/2019

Reason for recall

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

FDA-determined cause: Process control

Action taken

The recalling firm's sales representative telephoned their one customer on 1/12/2018 requesting return of the product.

Details

Recall number
Z-2378-2018
Initiated
January 12, 2018
Terminated
July 22, 2020
Product code
OFF – Central Venous Catheter Tray
Quantity
6/5-kit cases
Distribution
The product was distributed to UT.
Recalling firm
Medline Industries, Inc., Waukegan, IL

Official FDA recall record