International safety notice
As a result of an in-house investigation, it was confirmed that a different coloring agent was used than the one specified in the approval certificate, so we decided to discontinue using the product within its expiry date. I decided to collect it.
Japan / PMDA Recalls · JPN · Jun 20, 2023
Key facts
| Title | As a result of an in-house investigation, it was confirmed that a different coloring agent was used than the one specified in the approval certificate, so we decided to discontinue using the product within its expiry date. I decided to collect it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: (1) Polyester suture (2) Non-absorbable suture set Brand name: (1) Nespolen (2) Suture set with needle |
| Manufacturer | Alfresa Pharma Co., Ltd. |
| Models | 05586288, 12405, 04369936, 05470068, 05156788, 89248, 04724162, 05246410, 05207350, 05296033, 05084548, 04783701 and 126 more |
| Date | Jun 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