Device recall
Z-0461-2019: Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product…
FDA device recall · Class II · Covidien LLC
Key facts
| Recall number (Z-number) | Z-0461-2019 |
|---|---|
| Recall event | 81417 |
| Product | Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two-dimensional monofilament polyester central band. One side of the design is… |
| Product code | FTL |
| Recalling firm | Covidien LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 7, 2020 |
| 510(k) numbers | K081126, K142908 |
| FEI number | 1219930 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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