Device recall
Z-2222-2024: Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter…
FDA device recall · Class II · Cook Incorporated
Key facts
| Recall number (Z-number) | Z-2222-2024 |
|---|---|
| Recall event | 94696 |
| 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 |
| 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