Recall Z-1709-2015 ยท NGT Saline, Vascular Access Flush
MRP, LLC dba AMUSA
0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.
| Date | Jun 4, 2015 (initiated Apr 27, 2015) |
| Status | Terminated |
| Reason | Incorrect expiration date on label |
| Root cause | Process control |
| Action | The firm, AMUSA, sent a "Voluntary Recall Notification" dated 4/24/2015 to their consignees via Fed Ex on 04/27/2015. The letter described the product, problem and actions to be taken. The consignees were instructed to return any product remaining in the distribution channel to AMUSA; check with your product representative to determine if you have any of the listed products; if any product is located, call (615) 833-2633 from 8:30 am to 5:00 pm (Eastern Time) to receive instructions as to how to return the product; follow the enclosed Steps for Voluntary Recall in their entirety, and complete |
| Quantity | 200,000 units |
| Distribution | US Distribution in states of:OH, PA, AL, IL, TN, and CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133685 | 0.9% SODIUM CHLORIDE FLUSH SYRINGE Am USA, Aug 13, 2014 |