Drug product
0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015
D-1550-2014
Product summary
- Event
- Event 68089
- Status
- Terminated
- Classification
- Class I
- Quantity
- 4,200 containers
- Official record key
drug-enforcement:D-1550-2014
Official wording
Reason: Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes
Code information: Lot C931923, exp 8/31/2015
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter