Why it was recalled
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
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
Lot numbers, UPCs & expiration codes
Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023
Where it was sold
Distributed Nationwide in the USA to include Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0313-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 9, 2021
- FDA report date
- Mar 31, 2021
- Quantity
- 425,628 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ICU Medical Inc
Original FDA data
Every field from FDA enforcement report D-0313-2021, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 87484
- Address
- 600 N Field Dr
- Code information
- Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023
- Postal code
- 60045-4835
- Report date
- Mar 31, 2021
- Product type
- Drugs
- Recall number
- D-0313-2021
- Classification
- Class II
- Recalling firm
- ICU Medical Inc
- Product quantity
- 425,628 bottles
- Termination date
- Sep 28, 2022
- Reason for recall
- Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed Nationwide in the USA to include Puerto Rico
- Recall initiation date
- Mar 9, 2021
- Initial firm notification
- Letter
- Center classification date
- Mar 25, 2021