CLASS II Device recall · Reported 15 Jul 2020 · FDA Enforcement Report
Extra corporeal circuit with bio-active surface recalled
Medtronic Perfusion Systems is recalling Extra corporeal circuit with bio-active surface, distributed in California, Michigan. The recall was initiated on 8 Aug 2018 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-2495-2020
- FDA event ID
- 85821
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Aug 2018
- FDA classified
- 4 Jul 2020
- Reported
- 15 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 8 Aug 2018 | Recall initiated by company | |
| 4 Jul 2020 | Classified by FDA | +696 days |
| 15 Jul 2020 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Affected products failed a sterilization test.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Extra corporeal circuit with bio-active surface.
Where it was distributed
Domestic Distribution only to CA and MI.
Questions about this recall
Is Extra corporeal circuit with bio-active surface recalled?
Yes. Medtronic Perfusion Systems recalled Extra corporeal circuit with bio-active surface on 8 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-2495-2020.
Why was it recalled?
Affected products failed a sterilization test.
Which lots are affected?
Lot# 215729283
Where was it sold?
Domestic Distribution only to CA and MI.
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 21 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 Medtronic Perfusion Systems
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