International safety notice
Regarding the "Terfusion pump infusion set" (medical device), which is a component of the kit product manufactured and sold by our company. In order to maintain the bonding force between the tube and the lock connector, Terumo Corporation, the manufacturer and distributor, has released some products to maintain the bonding force between the tube and the lock connector. We received a notification that a product was shipped by mistake without undergoing the pre-treatment process. In response to this notification, we cannot deny the possibility that similar defects may occur in kit products manufactured and sold by our company. Therefore, we have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Sep 15, 2023
Key facts
| Title | Regarding the "Terfusion pump infusion set" (medical device), which is a component of the kit product manufactured and sold by our company. In order to maintain the bonding force between the tube and the lock connector, Terumo Corporation, the manufacturer and distributor, has released some products to maintain the bonding force between the tube and the lock connector. We received a notification that a product was shipped by mistake without undergoing the pre-treatment process. In response to this notification, we cannot deny the possibility that similar defects may occur in kit products manufactured and sold by our company. Therefore, we have decided to carry out a voluntary recall. |
|---|---|
| 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 | KS23970977, M01NEG010C |
| Date | Sep 15, 2023 |
| 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