T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile… recallZ-1808-2015 · MRP, LLC dba AMUSA · initiated Feb 9, 2015
Class II Terminated All recalls posted in June 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
Incorrect labeling of the expiration date
FDA root cause category: Process control
What the company is doing
The firm, AMUSA, Inc., initiated the recall by telephone to the sole consignee on 02/09/2015. The consignee were informed of product, the problem and actions to be taken. The consignees verified that they were in possession of the product and that all the product has been destroyed. If you have any questions, call 513-235-1940 or email: [email protected].
Recall details
- Recall number
- Z-1808-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 9, 2015
- Posted by the FDA
- Jun 15, 2015
- Recalling firm
- MRP, LLC dba AMUSA
- Quantity
- 1,080 units (3 cases)
- Product code
- NGT
- FDA submissions
- K120836
- Distribution
- US distribution to CA only.
Product description
T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.
Code information (models, lots, serial numbers)
KH04090
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.
How recalls are matched to devices · Editorial policy · Report an error on this page