medical Class II Updated 2021-10-13

Medtronic Perfusion Systems recalls Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pe

Recalled Product

Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.


Hazard / Issue

There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986.
View official government recall

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