Recall Z-2476-2015 ยท NGT Saline, Vascular Access Flush
MRP, LLC dba AMUSA
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
| Date | Aug 27, 2015 (initiated Jul 2, 2015) |
| Status | Terminated |
| Reason | Procedures for the acceptance and control of in-process product have not been adequately established. |
| Root cause | Packaging process control |
| Action | The firm notified their consignees of the recall by Fed Ex on 07/02/2015. The firm requested the return of the product. Distributors were instructed to notify their customers. |
| Quantity | 551 cases |
| Distribution | Distributed in the states of CA. PA, VA, TX, MA, MD, WV, UT, FL, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120836 | 0.9% SODIUM CHLORIDE FLISH SYRINGE Am USA, Jul 12, 2012 |