Recall Z-2393-2012
Amsino Medical USA · initiated August 15, 2012
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
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.
Codes / lots: KH03752
Reason for recall
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.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-2393-2012
- Initiated
- August 15, 2012
- Posted by FDA
- September 15, 2012
- Terminated
- August 13, 2013
- Product code
- NGT – Saline, Vascular Access Flush
- Quantity
- 196,400 units
- Distribution
- Distributed to one customer in Illinois.
- Recalling firm
- Amsino Medical USA, Nashville, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2394-2012 Class III | 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single…One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush… | 08/15/2012Terminated |