Class II
Terminated
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
- Company
- Icu Medical Inc
- Recall Initiated
- March 9, 2021
- Posted
- March 31, 2021
- Recall Number
- D-0313-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 425,628 bottles
- Firm Location
- Lake Forest, IL, United States
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
Lot / Code Info
Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023
More recalls by Icu Medical Inc
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Jan 16, 2026
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Jan 16, 2026
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Jan 16, 2026
Plum Duo Infusion System, List Number 40002-04-01
Jan 15, 2026
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