International safety notice
A medical institution has reported that the silk suture included in the product is of a different size than the specified size. There was a warning. Upon inspection at the manufacturing facility, it was confirmed that the suture was composed of a size 3-0 suture instead of the specified size 0. Incorrectly configured sutures are thinner than the specified sutures and, depending on how they are used, can pose a risk of suture failure. Therefore, we have decided to voluntarily recall all products in the affected lot.
Japan / PMDA Recalls · JPN · Dec 19, 2022
Key facts
| Title | A medical institution has reported that the silk suture included in the product is of a different size than the specified size. There was a warning. Upon inspection at the manufacturing facility, it was confirmed that the suture was composed of a size 3-0 suture instead of the specified size 0. Incorrectly configured sutures are thinner than the specified sutures and, depending on how they are used, can pose a risk of suture failure. Therefore, we have decided to voluntarily recall all products in the affected lot. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Single Use Class III Treatment Kit Sales name: Medline Surgical Custom Kit Surgical use |
| Manufacturer | Medline Japan LLC |
| Models | M23RES001F, KS2283040 |
| Date | Dec 19, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
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