Why it was recalled
Presence of Particulate Matter; stainless steel
Product description
0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-7983-09
Lot numbers, UPCs & expiration codes
Lot: 61-841-FW Exp. 01/01/2018
Where it was sold
Nationwide
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-1091-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 26, 2017
- FDA report date
- Aug 23, 2017
- Quantity
- 436,716 flexible containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ICU Medical Inc
Original FDA data
Every field from FDA enforcement report D-1091-2017, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 77824
- Address
- 600 N Field Dr
- Code information
- Lot: 61-841-FW Exp. 01/01/2018
- Postal code
- 60045-4835
- Report date
- Aug 23, 2017
- Product type
- Drugs
- Recall number
- D-1091-2017
- Classification
- Class II
- Recalling firm
- ICU Medical Inc
- Product quantity
- 436,716 flexible containers
- Termination date
- Mar 11, 2019
- Reason for recall
- Presence of Particulate Matter; stainless steel
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-7983-09
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 26, 2017
- Initial firm notification
- Press Release
- Center classification date
- Aug 14, 2017