CLASS II Device recall · Reported 14 Dec 2022 · FDA Enforcement Report
Medical Action Industries Inc. Port Access Kit recalled
Medical Action Industries Inc. 306 is recalling Medical Action Industries Inc. Port Access Kit, distributed in Minnesota. The recall was initiated on 12 Oct 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-0464-2023
- FDA event ID
- 91065
- Recalling firm
- Medical Action Industries Inc. 306, Arden, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Oct 2022
- FDA classified
- 8 Dec 2022
- Reported
- 14 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 12 Oct 2022 | Recall initiated by company | |
| 8 Dec 2022 | Classified by FDA | +57 days |
| 14 Dec 2022 | 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 Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits.
Product as listed by the FDA
Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit.
Where it was distributed
Distribution was made to MN. There was no foreign/government/military distribution.
Questions about this recall
Why was it recalled?
The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was correctly labeled as Port Access Kits.
Which lots are affected?
Port Access Kit case label - Lot 294281, exp. 9/28/2023, UDI #1080916018095. IV Start Kit label - Lot 294589, exp. 12/20/2024, UDI #20809160195991.
Where was it sold?
Distribution was made to MN. There was no foreign/government/military 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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