FDA recall D-0313-2021

Product

0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09

Reason for recall

Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use

Distribution

Distributed Nationwide in the USA to include Puerto Rico

Key facts

Status

Terminated

Initiation date

2021-03-09

Report date

2021-03-31

Termination date

2022-09-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0313-2021