0.9% Sodium Chloride Injection, USP, Pre-Filled Flush… recallZ-2393-2012 · Amsino Medical USA · initiated Aug 15, 2012
Class III Terminated All recalls posted in September 2012
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 Amsino Medical USA 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
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.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-2393-2012
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Aug 15, 2012
- Posted by the FDA
- Sep 15, 2012
- Recalling firm
- Amsino Medical USA
- Quantity
- 196,400 units
- Product code
- NGT
- FDA submissions
- K111034
- Distribution
- Distributed to one customer in Illinois.
Product description
0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Code information (models, lots, serial numbers)
KH03752
Other devices under the same FDA submission
2 devices cleared under K111034 — 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 2T0805Mrp, LLC · Saline, Vascular Access Flush2 reports
- Aquastat 2T0806Mrp, LLC · Saline, Vascular Access Flush2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 63105).
- Z-2394-2012 · Terminated0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc.,…
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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