FDA Medical Device Recalls (openFDA)
Cook Incorporated: 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.
- Recall number
- Z-0045-2025
- Recalling firm
- Cook Incorporated
- 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.
- Status
- Open, Classified
- Initiated
- 2024-09-16
- Posted
- 2024-10-09
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- 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 ausrecalls@cookmedical.com. 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 cau.complaints@cookmedical.com .
- Quantity
- 50 units
- Distribution
- International distribution to the country of Australia.
- Lot, serial or model codes
- UDI-DI: 00827002272422; Lot Number: 15506769
- 510(k) numbers
- K171999
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28