International safety notice
There is a possibility that gaps or wrinkles may have formed in the seal area during sterile pouch packaging for a particular lot of the product. We have decided to voluntarily recall the affected products as there is a possibility that they may be contaminated with products whose safety is not guaranteed.
Japan / PMDA Recalls · JPN · Dec 2, 2022
Key facts
| Title | There is a possibility that gaps or wrinkles may have formed in the seal area during sterile pouch packaging for a particular lot of the product. We have decided to voluntarily recall the affected products as there is a possibility that they may be contaminated with products whose safety is not guaranteed. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: (1) Polyester suture (2) Polypropylene suture (3) Polyamide suture thread (4) Sterilized silk suture thread (5) Polyester suture thread (6) Polybustel suture (7) Polyamide suture thread Sales name: (1) Surge Duck (2) Surge Pro II (3) Surgiron (4) Soft silk (5) Tyclone (6) Novafil (7) Monosof |
| Manufacturer | Covidien Japan Co., Ltd. |
| Models | D1M0640Y, D1L3383Y, 26-2022, D1J1929Y, D1K2644Y, 9-2022, D1M1286FY, 191971, D2C1101Y, D2D1396Y, SN1647, 1-2022 and 51 more |
| Date | Dec 2, 2022 |
| 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