Recalls / Class I
Class ID-1270-2020
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 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
- Affected lot / code info
- Lot #: 07-514-FW Exp. 01-JUL-2021
Why it was recalled
Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
Recalling firm
- Firm
- ICU Medical Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr, N/A, Lake Forest, Illinois 60045-4835
Distribution
- Quantity
- 93,648 flexible container
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-05-08
- FDA classified
- 2020-05-19
- Posted by FDA
- 2020-05-27
- Terminated
- 2021-11-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1270-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.