International safety notice
We received information from a medical institution that ``threads break easily,'' so we checked the stored items in that lot and found that one of them was found. A decrease in yarn strength was observed in some areas. Because of the undeniable possibility that products that do not meet the yarn strength standards may be mixed in, nine lots manufactured from the same raw yarn were I decided to collect it. ＊Recorded on November 2, 2014 Afterwards, in the process of investigating the cause and considering countermeasures using recovered items, it was discovered that the A seal failure was confirmed in the Lumi bag. It has been confirmed that there is a high possibility of this occurring due to the change, so products using aluminum bags manufactured after the change We have changed to collecting all items. Therefore, sterility is maintained even if a seal failure occurs.
Japan / PMDA Recalls · JPN · Sep 20, 2022
Key facts
| Title | We received information from a medical institution that ``threads break easily,'' so we checked the stored items in that lot and found that one of them was found. A decrease in yarn strength was observed in some areas. Because of the undeniable possibility that products that do not meet the yarn strength standards may be mixed in, nine lots manufactured from the same raw yarn were I decided to collect it. ＊Recorded on November 2, 2014 Afterwards, in the process of investigating the cause and considering countermeasures using recovered items, it was discovered that the A seal failure was confirmed in the Lumi bag. It has been confirmed that there is a high possibility of this occurring due to the change, so products using aluminum bags manufactured after the change We have changed to collecting all items. Therefore, sterility is maintained even if a seal failure occurs. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Polydioxanone Suture Sales name: Monodiox |
| Manufacturer | Alfresa Pharma Co., Ltd. |
| Models | 05444076, HR2003MV70‐KF2R, 05179312, 05291496, 05180493, 05234851, FJ3002MV70‐KJ2, 05509003, 05281664, 05190256, 04998570, 05446872 and 1194 more |
| Date | Sep 20, 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