Device product
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
Z-2223-2024
Product summary
- Event
- Event 94696
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-2223-2024
Official wording
Reason: Product labels state the incorrect expiration dates that extends beyond their true expiration date
Code information: UDI: (01)00827002097674(17)270228(10)15923728 Lot Number: 15923728
Distribution pattern: MA Foreign: Spain, and Netherlands
Derived failure modes
-
Unknown
Product labels state the incorrect expiration dates that extends beyond their true expiration date