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
Reported: March 31, 2021 Initiated: March 9, 2021 #D-0313-2021
Product Description
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
Details
- Recalling Firm
- ICU Medical Inc
- Units Affected
- 425,628 bottles
- Distribution
- Distributed Nationwide in the USA to include Puerto Rico
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by ICU Medical Inc. Units affected: 425,628 bottles.
Why was this product recalled? ▼
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 31, 2021. Severity: Moderate. Recall number: D-0313-2021.
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