FDA recall Z-2223-2024

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

Reason for recall

Product labels state the incorrect expiration dates that extends beyond their true expiration date

Distribution

MA Foreign: Spain, and Netherlands

Key facts

Status

Ongoing

Initiation date

2024-05-15

Report date

2024-07-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2223-2024