IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654… recallZ-1394-2024 · Medical Action Industries, Inc. 306 · initiated Jan 15, 2024
Open, Classified
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 Medical Action Industries, Inc. 306 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
The kits contain saline flush syringes which were recalled by the supplier.
FDA root cause category: Under Investigation by firm
What the company is doing
The recalling firm issued letters via email on 1/15/2024 explaining the details of the event and the actions to take. The consignee is to immediately discontinue use of all recalled Aquastat Prefilled Saline Flush 3mL & 5mL fill in 12mL Syringes contained in the kits. If the consignee has distributed kits containing these syringes, they are to notify their customers by including a copy of the recall letter. A warning label template was enclosed for the consignee to print which can be affixed on all affected kits in inventory. The warning label should be applied to each affected convenience kit and product case in a prominently visible location to the end user. The location of the warning label should not cover any other critical product information found on the existing product labeling. The Recall Response Form was to be completed and returned as soon as possible.
Recall details
- Recall number
- Z-1394-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 15, 2024
- Posted by the FDA
- Mar 28, 2024
- Recalling firm
- Medical Action Industries, Inc. 306
- Quantity
- 206,200 kits
- Product code
- LRS
- Distribution
- US Nationwide distribution in the states of MN and ND. There as no foreign/military/government distribution.
Product description
IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
Code information (models, lots, serial numbers)
Lot numbers 299477, 299849, 302983, 304173, 305500, 305501, 305514, 306363, 306683, 307030, 307809, 310701, 310887, 311741, 312807, and 313961;UDI-DI 10809160020388.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medical Action Industries 74654Medical Action Industries Inc. · I.V. start kit1 recall6 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 16, 2026. Text above is shown as published by the FDA.
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