FDA Device recall Z-0045-2025
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242
- FDA Device
- Class II
- ongoing
- Published 2024-10-16
On 2024-10-16 the FDA classified a Class II recall of Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242 by Cook, citing cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may dis….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0045-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-16 |
| Published | 2024-10-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cook |
| Distribution | n/a |
Product
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.
Reason
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
Identifiers
| code_info | UDI-DI: 00827002272422; Lot Number: 15506769 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0045-2025%22
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