Medtronic Perfusion Systems Recall 88685
Description: Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Medtronic Perfusion Systems Recall 88685 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0003-2022 |
| Event ID | 88685 |
| Event Description | Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile. |
| Product Type | Devices |
| 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 |
| Recall Reason | There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers. |
| Device Classification | 20211013 |
| Device Code Info | Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986. |
| Center Classification Date | 20211001 |
| Recall Initiation Date | 20210913 |
| Recalling Firm | Medtronic Perfusion Systems |
| Initial Notification | Letter |
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