Z-2476-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2015
- Initiation Date
- July 2, 2015
- Termination Date
- April 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 551 cases
Product Description
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
Reason for Recall
Procedures for the acceptance and control of in-process product have not been adequately established.
Distribution Pattern
Distributed in the states of CA. PA, VA, TX, MA, MD, WV, UT, FL, and TN.
Code Information
KH04143,exp. 07/2016; KH04145, exp. 08/2016; KH04153, exp. 11/2016; KH04155, exp. 12/2016