Why it was recalled
Presence of Particulate Matter.
Product description
LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03
Lot numbers, UPCs & expiration codes
Lot: 84-603-FW Exp. 01 DEC 2019
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-0349-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 25, 2019
- FDA report date
- Nov 13, 2019
- Quantity
- 389,808 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ICU Medical Inc
Original FDA data
Every field from FDA enforcement report D-0349-2020, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 84144
- Address
- 600 N Field Dr
- Code information
- Lot: 84-603-FW Exp. 01 DEC 2019
- Postal code
- 60045-4835
- Report date
- Nov 13, 2019
- Product type
- Drugs
- Recall number
- D-0349-2020
- Classification
- Class I
- Recalling firm
- ICU Medical Inc
- Product quantity
- 389,808 bags
- Termination date
- Jan 20, 2022
- Reason for recall
- Presence of Particulate Matter.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Oct 25, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 15, 2019