Recall Z-0003-2022— Medtronic Perfusion Systems
Class II · Ongoing
Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2021-09-13. It names one FDA 510(k) clearance: K190557. Product: Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.. Reason: There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers..
- Recalling firm
- Medtronic Perfusion Systems
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-09-13
- Firm location
- Brooklyn Park, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.