FDA Device recall Z-0003-2022
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile
- FDA Device
- Class II
- ongoing
- Published 2021-10-13
On 2021-10-13 the FDA classified a Class II recall of Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile by Medtronic Perfusion Systems, citing there was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0003-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-13 |
| Published | 2021-10-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | US |
Product
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
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.
Identifiers
| code_info | Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0003-2022%22
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