Why it was recalled
Lack of assurance of sterility: Bags have potential to leak.
Product description
0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
Lot numbers, UPCs & expiration codes
Lot #: 85-023-JT, Exp 7/1/2019
Where it was sold
Nationwide and Canada
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-0881-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 31, 2018
- FDA report date
- Jun 27, 2018
- Quantity
- 88960 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ICU Medical Inc
Original FDA data
Every field from FDA enforcement report D-0881-2018, exactly as published.
Show all FDA fields
- City
- LAKE FOREST
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 80213
- Address
- 600 N FIELD DRIVE
- Code information
- Lot #: 85-023-JT, Exp 7/1/2019
- Postal code
- 60045
- Report date
- Jun 27, 2018
- Product type
- Drugs
- Recall number
- D-0881-2018
- Classification
- Class II
- Recalling firm
- ICU Medical Inc
- Product quantity
- 88960 bags
- Termination date
- Jun 4, 2020
- Reason for recall
- Lack of assurance of sterility: Bags have potential to leak.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
- Distribution pattern
- Nationwide and Canada
- Recall initiation date
- May 31, 2018
- Initial firm notification
- Letter
- Center classification date
- Jun 20, 2018