Recall Z-1808-2015 ยท NGT Saline, Vascular Access Flush
MRP, LLC dba AMUSA
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.
| Date | Jun 15, 2015 (initiated Feb 9, 2015) |
| Status | Terminated |
| Reason | Incorrect labeling of the expiration date |
| Root cause | Process control |
| Action | The firm, AMUSA, Inc., initiated the recall by telephone to the sole consignee on 02/09/2015. The consignee were informed of product, the problem and actions to be taken. The consignees verified that they were in possession of the product and that all the product has been destroyed. If you have any questions, call 513-235-1940 or email: qadirector@amusa.us. |
| Quantity | 1,080 units (3 cases) |
| Distribution | US distribution to CA only. |
| 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 |