Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intende...
FDA Recall #Z-2222-2024 — Class II — May 15, 2024
Product Description
Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended 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: G09230
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)00827002092303(17)270228(10)NS15924530 Lot Number: NS15924530
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated