Medtronic Insertion Kits Recalled for Incorrect Guidewire Label Mix-Up
Medtronic is recalling 168 Bio-Medicus Insertion Kits because a label mix-up resulted in incorrect guidewires being packaged in both model types. The mislabeling could lead to use of the wrong component during insertion procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves an actual product mix-up where insertion kits contain incorrect guidewires due to label confusion. While no illnesses or injuries have been reported, the defect poses a direct risk of harm if the incorrect guidewire is used during insertion procedures.
Plain-English summary
Medtronic Perfusion Systems is recalling 168 Bio-Medicus Insertion Kits, comprised of Model 96553 (Pediatric Insertion Kit, Sterile) and Model 96551 (Venous Insertion Kit, Sterile). These are sterile medical devices designed for use in insertion procedures.
A label mix-up between the two model numbers resulted in the incorrect guidewire being packaged inside the kits for both model numbers. This labeling error means that kits identified with one model number may contain the guidewire specified for the other model, creating a potential mismatch between the kit label and the actual component inside.
The affected kits were distributed worldwide, with US nationwide distribution in Massachusetts and international distribution to Belgium, France, Germany, Japan, Korea, Saudi Arabia, Spain, and Turkey. Specific lot numbers and serial numbers for the affected products have been identified.
Healthcare providers who have received these insertion kits should immediately stop using them and contact Medtronic Perfusion Systems for replacement kits. Do not use any kits suspected of being affected by this label mix-up until replacements are obtained.
The recalled product
- Product
- Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device — Insertion Kits
- Affected units
- 168
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model 96553 - Serial number 220719040
- GTIN 20763000116006
- Model 96551 - Serial number 220641720
- GTIN 20763000115986.
Distribution
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