Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Recall
- Recall Number
- Z-0003-2022
- Event Number
- 88685
- Firm
- Medtronic Perfusion Systems
- FEI Number
- 1000116158
- Product Code
- DWF
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- September 13, 2021
- Address
- 7611 Northland Dr N, Brooklyn Park, MN, 55428-1088
Description
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
The recalling firm issued letters dated September 2021 beginning 9/13/2021 via 2-day UPS delivery to consignees. For outside of the United States, the recall letter will be delivered via regionally-approved methods to consignees who received the product. The letter explains the issue and requests the consignee review their inventory for the affected product. The product is to be immediately quarantined and returned after first contacting Customer Service. A Customer Confirmation Form was enclosed to be returned via email. The letter was to be shared with others within their organization as appropriate and to any other locations who have received the product through a transfer. Consignees are asked to review the Medtronic Urgent Medical Device Recall notification and follow the Recommended Actions, including quarantining and returning all unused affected Bio-Medicus Insertion Kits in their inventory.
Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.
168 kits