0.9% SODIUM CHLORIDE Irrigation recall: Particulate Matter
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC…
Why was 0.9% SODIUM CHLORIDE Irrigation recalled?
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023
- 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…
- Recalling firm
- ICU Medical Inc
- Quantity
- 425,628 bottles
- Distribution
- Distributed Nationwide in the USA to include Puerto Rico
- Recall date
- March 31, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)