Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous
FDA device recall Z-2223-2024 · posted 2024-06-27 · Open, Classified
Recall details
- Recalling firm
- Cook Incorporated
- Reason for recall
- Product labels state the incorrect expiration dates that extends beyond their true expiration date
- Action taken
- Cook issued Urgent Medical Device Correction letter mailed via courier to the impacted U.S consignee on 5/16/24. Letter states reason for recall, health risk and action to take: Actions to be Taken by the Customer 1. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected products have been transferred. 2. Examine inventory immediately to determine if you have affected product(s) in your inventory that remain unused. If you have affected product(s) remaining within your inventory: a. You should retain a copy of this letter in an easily accessible location and/or attach a copy of this letter to the affected product. b. You may continue to use affected products. Cook Medical is not requesting product be returned. 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).
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- FGE
- Quantity affected
- 15 units
- Distribution
- MA Foreign: Spain, and Netherlands
- Date initiated
- 2024-05-15
- Date posted
- 2024-06-27
- Location
- Bloomington, IN
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