CLASS II Device recall · Reported 27 Oct 2021 · FDA Enforcement Report
Kit: Central Line Dres Change 20/Cs recalled
Medical Action Industries Inc. 306 is recalling Kit: Central Line Dres Change 20/Cs, distributed in Michigan. The recall was initiated on 8 Sep 2021 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-0147-2022
- FDA event ID
- 88687
- Recalling firm
- Medical Action Industries Inc. 306, Arden, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Sep 2021
- FDA classified
- 19 Oct 2021
- Reported
- 27 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 8 Sep 2021 | Recall initiated by company | |
| 19 Oct 2021 | Classified by FDA | +41 days |
| 27 Oct 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.
Product as listed by the FDA
Kit: Central Line Dres Change 20/Cs
Where it was distributed
Distribution to a single US distributor in Michigan
Questions about this recall
Why was it recalled?
The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.
Which lots are affected?
Product Code: 59815B, Batch 0000285665; Kit expiration date 03/31/2024 UDI: 20809160170523
Where was it sold?
Distribution to a single US distributor in Michigan
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.
More recalls from Medical Action Industries Inc. 306
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