Device product
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
Z-2476-2015
Product summary
- Event
- Event 71735
- Status
- Terminated
- Classification
- Class II
- Quantity
- 551 cases
- Official record key
device-enforcement:Z-2476-2015
Official wording
Reason: Procedures for the acceptance and control of in-process product have not been adequately established.
Code information: KH04143,exp. 07/2016; KH04145, exp. 08/2016; KH04153, exp. 11/2016; KH04155, exp. 12/2016
Distribution pattern: Distributed in the states of CA. PA, VA, TX, MA, MD, WV, UT, FL, and TN.
Derived failure modes
-
Unknown
Procedures for the acceptance and control of in-process product have not been adequately established.