Recalls / Class I
Class ID-0350-2020
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
0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25
- Affected lot / code info
- Lot: 95-101-C6 Exp. 01 MAY 2020
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
- 58,464 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-0350-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.