FDA recall Z-2378-2018

Medline Industries, Inc. · Class II · device

Product

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.

Distribution

The product was distributed to UT.

Key facts

Status
Terminated
Initiation date
2018-01-12
Report date
2018-07-18
Termination date
2020-07-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2378-2018