FDA recall Z-1387-2018

Product

Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and transplantation into a recipient.

Reason for recall

Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag..

Distribution

Worldwide Distribution -- USA and Europe.

Key facts

Status

Terminated

Initiation date

2018-02-26

Report date

2018-04-25

Termination date

2022-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Elkhorn, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1387-2018