CLASS II Device recall · Reported 2 Mar 2022 · FDA Enforcement Report
Michels Transport Medium Prefilled Cont recalled
Medline Industries LP - Northfield is recalling Michels Transport Medium Prefilled Cont, distributed nationwide in the US. The recall was initiated on 1 Dec 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-0656-2022
- FDA event ID
- 89164
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Dec 2021
- FDA classified
- 18 Feb 2022
- Reported
- 2 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 1 Dec 2021 | Recall initiated by company | |
| 18 Feb 2022 | Classified by FDA | +79 days |
| 2 Mar 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product stored incorrectly in temperature controlled setting instead of refrigeration.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Michels Transport Medium, 20ML Prefilled Cont
Where it was distributed
US Nationwide distribution in the states of Colorado, Florida, New York, North Carolina, and Texas.
Questions about this recall
Why was it recalled?
Product stored incorrectly in temperature controlled setting instead of refrigeration.
Which lots are affected?
Model Number: AZSES3270, all lots with expiration date range of 08/28/2021 through 09/03/2023
Where was it sold?
US Nationwide distribution in the states of Colorado, Florida, New York, North Carolina, and Texas.
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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