0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single… recallZ-2476-2015 · MRP, LLC dba AMUSA · initiated Jul 2, 2015
Class II Terminated All recalls posted in August 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MRP, LLC dba AMUSA or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Procedures for the acceptance and control of in-process product have not been adequately established.
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-2476-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 2, 2015
- Posted by the FDA
- Aug 27, 2015
- Recalling firm
- MRP, LLC dba AMUSA
- Quantity
- 551 cases
- Product code
- NGT
- FDA submissions
- K120836
- Distribution
- Distributed in the states of CA. PA, VA, TX, MA, MD, WV, UT, FL, and TN.
Product description
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
Code information (models, lots, serial numbers)
KH04143,exp. 07/2016; KH04145, exp. 08/2016; KH04153, exp. 11/2016; KH04155, exp. 12/2016
Other devices under the same FDA submission
1 device cleared under K120836 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Aquastat SFR 2S0706Mrp, LLC · Saline, Vascular Access Flush8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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