Z-0003-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 13, 2021
- Initiation Date
- September 13, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 168 kits
Product Description
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
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 Pattern
Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.
Code Information
Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986.