Z-0045-2025 Class II Ongoing
FDA device recall Z-0045-2025 was initiated by Cook Incorporated on September 16, 2024 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2024
- Initiation Date
- September 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
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 for Recall
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.
Distribution Pattern
International distribution to the country of Australia.
Code Information
UDI-DI: 00827002272422; Lot Number: 15506769