Drug 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
D-1091-2017
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 77824
- Status
- Terminated
- Classification
- Class II
- Quantity
- 436,716 flexible containers
- Official record key
drug-enforcement:D-1091-2017
Official wording
Reason: Presence of Particulate Matter; stainless steel
Code information: Lot: 61-841-FW Exp. 01/01/2018
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter