0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078
FDA device recall Z-2393-2012 · posted 2012-09-15 · Terminated
Recall details
- Recalling firm
- Amsino Medical USA
- 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.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- NGT
- Quantity affected
- 196,400 units
- Distribution
- Distributed to one customer in Illinois.
- Date initiated
- 2012-08-15
- Date posted
- 2012-09-15
- Date terminated
- 2013-08-13
- Location
- Nashville, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE (K111034) | Am USA | 2011-07-14 |