Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 168 Perfusion System insertion kits due to a labeling mix-up that resulted in incorrect guidewires being included in the kits. The affected products are the Bio-Medicus Pediatric Insertion Kit (Model 96553, Serial number 220719040) and the Bio-Medicus Venous Insertion Kit (Model 96551, Serial number 220641720). These kits were distributed worldwide, including throughout the United States, Massachusetts, Belgium, France, Germany, Japan, Korea, Saudi Arabia, Spain, and Turkey.
The record does not specify a remedy or action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
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. 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. Quantity: 168 kits Lot/code info: Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.