FDA-Device2024-07-03Class II

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

Cook Incorporated
Hazard

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

Sold states
MA Foreign: Spain, and Netherlands
Affected count
15 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2222-2024

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