Recalls / Class II
Class IID-1091-2017
Product
0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-7983-09
- Affected lot / code info
- Lot: 61-841-FW Exp. 01/01/2018
Why it was recalled
Presence of Particulate Matter; stainless steel
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
- 436,716 flexible containers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-07-26
- FDA classified
- 2017-08-14
- Posted by FDA
- 2017-08-23
- Terminated
- 2019-03-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1091-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.