International safety notice
ICU Medical, a foreign special certification holder, has provided two halves that make up the connection in a specific lot number of the product. Have there been any reports of potential manufacturing defects that have resulted in visible gaps between the housings? Therefore, we have decided to carry out a voluntary recall of products with the corresponding lot numbers shipped to the Japanese market.
Japan / PMDA Recalls · JPN · Aug 17, 2022
Key facts
| Title | ICU Medical, a foreign special certification holder, has provided two halves that make up the connection in a specific lot number of the product. Have there been any reports of potential manufacturing defects that have resulted in visible gaps between the housings? Therefore, we have decided to carry out a voluntary recall of products with the corresponding lot numbers shipped to the Japanese market. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Intravenous catheter adapter Brand name: SurePlug CL |
| Manufacturer | Corbridge Co., Ltd. |
| Models | 5755100, 11000, 5728008, 5727531, IR-1S, IR-1SF, 5737373, 5738091 |
| Date | Aug 17, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 100–999 Matching device models in FDA data
- 100–999 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