Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-n...
FDA Recall #Z-2223-2024 — Class II — May 15, 2024
Product Description
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
Reason for Recall
Product labels state the incorrect expiration dates that extends beyond their true expiration date
Recalling Firm
Cook Incorporated — Bloomington, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
15 units
Distribution
MA Foreign: Spain, and Netherlands
Code Information
UDI: (01)00827002097674(17)270228(10)15923728 Lot Number: 15923728
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated