Recall Z-2393-2012 ยท NGT Saline, Vascular Access Flush
Amsino Medical USA
0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
| Date | Sep 15, 2012 (initiated Aug 15, 2012) |
| Status | Terminated |
| Reason | One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL. |
| Root cause | Employee error |
| Action | The firm, Amusa, notified their sole consignee of the mislabeled product via e-mail and telephone on August 15, 2012. An "URGENT-CLASS II MEDICAL DEVICE RECALL" letter dated August 22, 2012 was sent to the customer. The letter identified the product, problem, and actions to be taken by the customer. A Response Form was included for the customer to complete and return. Contact the firm at 615-521-2723 for questions regarding this recall. |
| Quantity | 196,400 units |
| Distribution | Distributed to one customer in Illinois. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111034 | AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE Am USA, Jul 14, 2011 |