FDA Medical Device Recalls (openFDA)
MRP, LLC dba AMUSA: 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
- Recall number
- Z-2476-2015
- Recalling firm
- MRP, LLC dba AMUSA
- Product
- 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
- Status
- Terminated
- Initiated
- 2015-07-02
- Posted
- 2015-08-27
- Terminated
- 2017-04-03
- Reason
- Procedures for the acceptance and control of in-process product have not been adequately established.
- Root cause
- Packaging process control
- Action
- 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.
- Quantity
- 551 cases
- Distribution
- Distributed in the states of CA. PA, VA, TX, MA, MD, WV, UT, FL, and TN.
- Lot, serial or model codes
- KH04143,exp. 07/2016; KH04145, exp. 08/2016; KH04153, exp. 11/2016; KH04155, exp. 12/2016
- 510(k) numbers
- ["K120836"]
- PMA numbers
- not on file
- Product code
- NGT
- Firm FEI
- 1000151124
- Firm city
- Nashville
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28