Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G089

FDA device recall Z-1787-2025 · posted 2025-05-16 · Open, Classified

Recall details

Recalling firm

Cook Incorporated

Reason for recall

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

Action taken

Cook Medical issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 04/17/2025 via FedEx Standard Overnight. The notice explained the issue, potential risk to health and requested: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of 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. You may return the Form via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DYB

Quantity affected

89 units

Distribution

Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.

Date initiated

2025-04-17

Date posted

2025-05-16

Location

Bloomington, IN