Drug recall
Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20…
FDA recall event 81417 · Class II · Covidien LLC
Key facts
| Event ID | 81417 |
|---|---|
| Recall numbers | Z-0461-2019 |
| Recalling firm | Covidien LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair… |
| Initiation date | Oct 5, 2018 |
| Report date | Nov 21, 2018 |
| Termination date | May 7, 2020 |
| City | North Haven |
| State | CT |
| Country | United States |
| FEI number | 1219930 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: