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

FDA device recall Z-0045-2025 · posted 2024-10-09 · Open, Classified

Recall details

Recalling firm

Cook Incorporated

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.

Action taken

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 .

Root cause

Process control

Status

Open, Classified

Product code

DYB

Quantity affected

50 units

Distribution

International distribution to the country of Australia.

Date initiated

2024-09-16

Date posted

2024-10-09

Location

Bloomington, IN

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