Device product
0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Z-2394-2012
Product summary
- Event
- Event 63105
- Status
- Terminated
- Classification
- Class III
- Quantity
- unknown
- Official record key
device-enforcement:Z-2394-2012
Official wording
Reason: One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL.
Code information: KH03752
Distribution pattern: Distributed to one customer in Illinois.
Derived failure modes
-
Labeling or packaging
mislabeled