Device recall

Z-2223-2024: Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage…

FDA device recall · Class II · Cook Incorporated

Key facts

Recall number (Z-number) Z-2223-2024
Recall event 94696
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
Product code FGE
Recalling firm Cook Incorporated
Recall class Class II
Status Open, Classified
510(k) numbers K173035
FEI number 1820334

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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