Why it was recalled
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Product description
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Lot numbers, UPCs & expiration codes
Lot: 5829936, Exp. MAR 31 2024
Where it was sold
Nationwide in the USA
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-0062-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 9, 2022
- FDA report date
- Nov 23, 2022
- Quantity
- 137,120 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ICU Medical Inc
Original FDA data
Every field from FDA enforcement report D-0062-2023, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 91113
- Address
- 600 N Field Dr
- Code information
- Lot: 5829936, Exp. MAR 31 2024
- Postal code
- 60045-4835
- Report date
- Nov 23, 2022
- Product type
- Drugs
- Recall number
- D-0062-2023
- Classification
- Class II
- Recalling firm
- ICU Medical Inc
- Product quantity
- 137,120 bags
- Reason for recall
- Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 9, 2022
- Initial firm notification
- Letter
- Center classification date
- Nov 16, 2022