Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Reported: October 13, 2021 Initiated: September 13, 2021 #Z-0003-2022
Product Description
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
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.
Details
- Recalling Firm
- Medtronic Perfusion Systems
- Units Affected
- 168 kits
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.
- Location
- Brooklyn Park, MN
Frequently Asked Questions
What product was recalled? ▼
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.. Recalled by Medtronic Perfusion Systems. Units affected: 168 kits.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on October 13, 2021. Severity: Moderate. Recall number: Z-0003-2022.
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