Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789

FDA device recall Z-0499-2025 · posted 2024-11-21 · Open, Classified

Recall details

Recalling firm

Cook Incorporated

Reason for recall

Devices from the affected device lots have labels that state the incorrect expiration dates.

Action taken

An "URGENT: MEDICAL DEVICE RECALL" notification letter dated 10/14/24 was sent to customers. 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. Action being Taken by Cook Medical Cook Medical is removing affected products from the market. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500.

Root cause

Labeling Change Control

Status

Open, Classified

Product code

DQX

Quantity affected

10 units

Distribution

International Distribution to: Korea only

Date initiated

2024-10-14

Date posted

2024-11-21

Location

Bloomington, IN

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