CLASS II ONGOING Device recall · Reported 3 Apr 2024 · FDA Enforcement Report

IV Start Kit, containing 1 Saline Syringe recalled

Medical Action Industries Inc. 306 is recalling IV Start Kit, containing 1 Saline Syringe, distributed nationwide in the US. The recall was initiated on 15 Jan 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers 299477, 299849, 302983, 304173, 305500, 305501, 305514, 306363, 306683, 307030, 307809, 310701, 310887, 311741, 312807, and 313961;UDI-DI 10809160020388.
Quantity recalled206,200 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1394-2024
FDA event ID
94181
Recalling firm
Medical Action Industries Inc. 306, Arden, NC
Classification
Class II
Status
Ongoing
Recall initiated
15 Jan 2024
FDA classified
28 Mar 2024
Reported
3 Apr 2024
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

15 Jan 2024Recall initiated by company
28 Mar 2024Classified by FDA+73 days
3 Apr 2024Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The kits contain saline flush syringes which were recalled by the supplier.

Product as listed by the FDA

IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.

Where it was distributed

US Nationwide distribution in the states of MN and ND. There as no foreign/military/government distribution.

Nationwide MinnesotaNorth Dakota

Questions about this recall

Why was it recalled?

The kits contain saline flush syringes which were recalled by the supplier.

Which lots are affected?

Lot numbers 299477, 299849, 302983, 304173, 305500, 305501, 305514, 306363, 306683, 307030, 307809, 310701, 310887, 311741, 312807, and 313961;UDI-DI 10809160020388.

Where was it sold?

US Nationwide distribution in the states of MN and ND. There as no foreign/military/government distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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