Z-2222-2024 Class II Ongoing
FDA device recall Z-2222-2024 was initiated by Cook Incorporated on May 15, 2024 and is designated Class II. Reason for recall: Product labels state the incorrect expiration dates that extends beyond their true expiration date The recall status is ongoing. Affected quantity: 15 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 3, 2024
- Initiation Date
- May 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
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
Distribution Pattern
MA Foreign: Spain, and Netherlands
Code Information
UDI: (01)00827002092303(17)270228(10)NS15924530 Lot Number: NS15924530
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2222-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026