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
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
- Device type
- Syringes & Needles
Timeline
| 15 Jan 2024 | Recall initiated by company | |
| 28 Mar 2024 | Classified by FDA | +73 days |
| 3 Apr 2024 | Published 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.
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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