CLASS II Device recall · Reported 23 Jun 2021 · FDA Enforcement Report
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC recalled
Medtronic Perfusion Systems is recalling Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, distributed nationwide in the US. The recall was initiated on 29 Apr 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-1871-2021
- FDA event ID
- 87915
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Apr 2021
- FDA classified
- 16 Jun 2021
- Reported
- 23 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 29 Apr 2021 | Recall initiated by company | |
| 16 Jun 2021 | Classified by FDA | +48 days |
| 23 Jun 2021 | 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
Specific lots may have been manufactured with insufficient or incomplete welds.
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
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Where it was distributed
US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.
Nationwide AlabamaArizonaCaliforniaIndianaKentuckyMassachusettsOhioTennesseeTexas
Questions about this recall
Is Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System recalled?
Yes. Medtronic Perfusion Systems recalled Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System on 29 Apr 2021. The recall is Class II and its status is Terminated. Recall number Z-1871-2021.
Why was it recalled?
Specific lots may have been manufactured with insufficient or incomplete welds.
Which lots are affected?
GTIN 00763000292034, Lot #220866332, Use By 2022-09-29
Where was it sold?
US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. 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 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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