Recall Z-2223-2024 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cook Incorporated
Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER: GPN:G09767
| Date | Jun 27, 2024 (initiated May 15, 2024) |
| Status | Open, Classified |
| Reason | Product labels state the incorrect expiration dates that extends beyond their true expiration date |
| Root cause | Labeling Change Control |
| Action | 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: |
| Quantity | 15 units |
| Distribution | MA Foreign: Spain, and Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173035 | Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Cook Incorporated, May 1, 2018 |