Device product
T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.
Z-1808-2015
Product summary
- Event
- Event 70974
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,080 units (3 cases)
- Official record key
device-enforcement:Z-1808-2015
Official wording
Reason: Incorrect labeling of the expiration date
Code information: KH04090
Distribution pattern: US distribution to CA only.
Derived failure modes
-
Labeling or packaging
Incorrect labeling