0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
FDA device recall Z-2476-2015 · posted 2015-08-27 · Terminated
Recall details
- Recalling firm
- MRP, LLC dba AMUSA
- Reason for recall
- Procedures for the acceptance and control of in-process product have not been adequately established.
- Action taken
- The firm notified their consignees of the recall by Fed Ex on 07/02/2015. The firm requested the return of the product. Distributors were instructed to notify their customers.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- NGT
- Quantity affected
- 551 cases
- Distribution
- Distributed in the states of CA. PA, VA, TX, MA, MD, WV, UT, FL, and TN.
- Date initiated
- 2015-07-02
- Date posted
- 2015-08-27
- Date terminated
- 2017-04-03
- 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 |
|---|---|---|
| 0.9% SODIUM CHLORIDE FLISH SYRINGE (K120836) | Am USA | 2012-07-12 |