CLASS II ONGOING Device recall · Reported 13 Oct 2021 · FDA Enforcement Report
Medtronic Bio-Medicus Insertion Kits recalled
Medtronic Perfusion Systems is recalling Medtronic Bio-Medicus Insertion Kits, distributed nationwide in the US. The recall was initiated on 13 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-0003-2022
- FDA event ID
- 88685
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Sep 2021
- FDA classified
- 1 Oct 2021
- Reported
- 13 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 13 Sep 2021 | Recall initiated by company | |
| 1 Oct 2021 | Classified by FDA | +18 days |
| 13 Oct 2021 | 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
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
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 Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Where it was distributed
Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.
Questions about this recall
Is Medtronic Bio-Medicus Insertion Kits recalled?
Yes. Medtronic Perfusion Systems recalled Medtronic Bio-Medicus Insertion Kits on 13 Sep 2021. The recall is Class II and its status is Ongoing. Recall number Z-0003-2022.
Why was it recalled?
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Which lots are affected?
Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986.
Where was it sold?
Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.
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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