Medtronic recalls two pediatric insertion kit models due to label mix-up causing incorrect guidewire in kits. Affected kits have specific serial numbers and GTINs.
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Medtronic is recalling two pediatric insertion kits (model 96553 and 96551) because a label mix-up means the wrong guidewire could be in the kits. This could lead to incorrect medical procedures if used.
A label mix-up caused the incorrect guidewire to be included in both kit models. Using the wrong guidewire could lead to incorrect medical procedures during pediatric procedures.
Healthcare professionals using these kits for pediatric procedures are most at risk. The recall affects specific kits with known serial numbers and GTINs.
Check for model numbers 96553 (Pediatric Insertion Kit) or 96551 (Venous Insertion Kit). Look for serial numbers 220719040 or 220641720 and GTINs 20763000116006 or 20763000115986.
Verify the model number on the kit packaging to confirm it is either 96553 or 96551.
Check for the specific serial numbers 220719040 (model 96553) or 220641720 (model 96551).
A label mix-up caused the incorrect guidewire to be included in both kit models, which could lead to incorrect medical procedures during pediatric procedures.
Model 96553 (Pediatric Insertion Kit) and model 96551 (Venous Insertion Kit).
Check for model numbers 96553 or 96551, and look for serial numbers 220719040 or 220641720 with GTINs 20763000116006 or 20763000115986.
We’ve drafted a message you can send Medtronic Perfusion Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0003-2022 — Medtronic Perfusion Systems Medtronic Perfusion Systems Hello, I own a Medtronic Perfusion Systems that is covered by recall Z-0003-2022 from Medtronic Perfusion Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.