Device product
0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.
Z-1709-2015
Product summary
- Event
- Event 71175
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200,000 units
- Official record key
device-enforcement:Z-1709-2015
Official wording
Reason: Incorrect expiration date on label
Code information: CODES: KH04103, KH04104, KH04105
Distribution pattern: US Distribution in states of:OH, PA, AL, IL, TN, and CT.
Derived failure modes
-
Unknown
Incorrect expiration date on label