Performer recallZ-0045-2025 · Cook Incorporated · initiated Sep 16, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cook Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
An URGENT: MEDICAL DEVICE RECALL notification letter dated 9/13/24 was sent to customers. Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product s from the lot listed above. If so, quarantine any affected products that remain unused. Immediately cease all further distribution and use o f the affected products. 2. Return the affected product s to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand and email the completed form to [email protected]. 4. Please share this notice with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected products have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 1800 777 222 or by email at [email protected] .
Recall details
- Recall number
- Z-0045-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 16, 2024
- Posted by the FDA
- Oct 9, 2024
- Recalling firm
- Cook Incorporated
- Quantity
- 50 units
- Product code
- DYB
- FDA submissions
- K171999
- Distribution
- International distribution to the country of Australia.
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.
Code information (models, lots, serial numbers)
UDI-DI: 00827002272422; Lot Number: 15506769
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Performer G27242Cook Incorporated · INTRODUCER, CATHETER1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page