International safety notice
Due to a problem with the adhesive of the component parts of the target product (repair kit) in Japan and overseas, the adhesive has hardened before use. We have received notification from the manufacturer that an event has occurred that makes the product unusable, so we have decided to voluntarily return the product of a specific lot (manufacturing number). We have decided to carry out a collection.
Japan / PMDA Recalls · JPN · Dec 16, 2022
Key facts
| Title | Due to a problem with the adhesive of the component parts of the target product (repair kit) in Japan and overseas, the adhesive has hardened before use. We have received notification from the manufacturer that an event has occurred that makes the product unusable, so we have decided to voluntarily return the product of a specific lot (manufacturing number). We have decided to carry out a collection. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Central venous catheter introducer kit Brand name: (1) Broviac Catheter Kit (2) Hickman catheter kit |
| Manufacturer | Medicon Co., Ltd. |
| Models | 60176, REGP2720, REEU0726, REEU1534, 60162, 60161, REFX4541, REEU1536, REEU3300 |
| Date | Dec 16, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers 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