Z-0045-2025Class II

Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer...

Name: Z-0045-2025 Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer...
Creator: Cook Incorporated
Published: 2024-09-16
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2024-09-16 / Open, Classified / root cause: manufacturing process

FDA source

Cook Incorporated began a recall of 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... on 2024-09-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0045-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-16
Posted: 2024-10-09
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.
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA 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 [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] .
Quantity in commerce: 50 units
Distribution: International distribution to the country of Australia.
Product codes and lots: UDI-DI: 00827002272422; Lot Number: 15506769

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0045-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0045-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-09

Product code DYB

K171999Class IIPerformer IntroducerCook Incorporated / cleared 2017-07-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)