CLASS II Device recall · Reported 28 Dec 2022 · FDA Enforcement Report
Medical Action Industries INC. Port a Cath Kit recalled
Medical Action Industries Inc. 306 is recalling Medical Action Industries INC. Port a Cath Kit, distributed nationwide in the US. The recall was initiated on 4 Nov 2022 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-0751-2023
- FDA event ID
- 91180
- Recalling firm
- Medical Action Industries Inc. 306, Arden, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Nov 2022
- FDA classified
- 21 Dec 2022
- Reported
- 28 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 4 Nov 2022 | Recall initiated by company | |
| 21 Dec 2022 | Classified by FDA | +47 days |
| 28 Dec 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
XXX
Product as listed by the FDA
Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
Where it was distributed
US Nationwide distribution in the state of VA.
Questions about this recall
Why was it recalled?
XXX
Which lots are affected?
UDI/DI 10809160156681, Lot Numbers: 297223, 297418
Where was it sold?
US Nationwide distribution in the state of VA.
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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| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |