International safety notice
By December 2020, our company will have released Paritex Composite Mesh (Hiare), a mesh for hiatal hernia repair. Regarding 1 product number (PCO2H3: 3D 9 x 8cm) and 1 lot (PVE0194M) of barrel type), collagen film is mesh We have received two complaints from customers about being placed on opposite sides. It was confirmed that the cause was that the collagen film was placed on the opposite side during the original production of the lot. Ta.
Japan / PMDA Recalls · JPN · Jan 20, 2023
Key facts
| Title | By December 2020, our company will have released Paritex Composite Mesh (Hiare), a mesh for hiatal hernia repair. Regarding 1 product number (PCO2H3: 3D 9 x 8cm) and 1 lot (PVE0194M) of barrel type), collagen film is mesh We have received two complaints from customers about being placed on opposite sides. It was confirmed that the cause was that the collagen film was placed on the opposite side during the original production of the lot. Ta. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Absorbent ヘルニア・chest wall and abdominal wall repair materials Sales name: Paritex Composite Mesh |
| Manufacturer | Covidien Japan Co., Ltd. |
| Models | PVE0194M, PCO2H3 |
| Date | Jan 20, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1