Recalls / Class I
Class ID-0349-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03
- Affected lot / code info
- Lot: 84-603-FW Exp. 01 DEC 2019
Why it was recalled
Presence of Particulate Matter.
Recalling firm
- Firm
- ICU Medical Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr, N/A, Lake Forest, Illinois 60045-4835
Distribution
- Quantity
- 389,808 bags
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2019-10-25
- FDA classified
- 2019-11-15
- Posted by FDA
- 2019-11-13
- Terminated
- 2022-01-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0349-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.