Reported Oct 13, 2021 · Ongoing
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551,…
Medtronic Perfusion Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
- Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
- Lot codes and dates
Model 96553 - Serial number 220719040GTIN 20763000116006Model 96551 - Serial number 220641720GTIN 20763000115986
- Amount recalled
- 168 kits
Where it was sold
- Nationwide
- MA
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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