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FDASeptember 13, 2021device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

medtronic perfusion systemsmedtronicmedtronic perfusion

UPCs

2076300011600620763000115986

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile. — Recall Details · AllClear