FDA recall Z-2222-2024

Product

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

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-2222-2024