Recalls / Class II
Class IID-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
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Irrigation
- NDCs
- 0990-6138, 0990-7138, 0990-7972
- FDA application
- NDA017514
- Affected lot / code info
- Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023
Why it was recalled
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Recalling firm
- Firm
- ICU Medical Inc
- Manufacturer
- ICU Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr, N/A, Lake Forest, Illinois 60045-4835
Distribution
- Quantity
- 425,628 bottles
- Distribution pattern
- Distributed Nationwide in the USA to include Puerto Rico
Timeline
- Recall initiated
- 2021-03-09
- FDA classified
- 2021-03-25
- Posted by FDA
- 2021-03-31
- Terminated
- 2022-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0313-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.