International safety notice
In the name of our sales name "Parapack Plus", the ventilation connector of the patient circuit connection part is loosened or deviated. However, it became clear that it could affect the ventilation function. Thank you. We will provide new information regarding future responses as soon as the method of response is determined. I did. Now that we are ready to repair the parts, we will carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Jan 21, 2025
Key facts
| Title | In the name of our sales name "Parapack Plus", the ventilation connector of the patient circuit connection part is loosened or deviated. However, it became clear that it could affect the ventilation function. Thank you. We will provide new information regarding future responses as soon as the method of response is determined. I did. Now that we are ready to repair the parts, we will carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: portable artificial respirator Sales name: Parapack Plus |
| Manufacturer | Smith Medical Japan Co., Ltd. |
| Models | 1702096, 1802133, 2010019, 2301150, 2107080, 1802075, 1702080, 1802072, 2210157, 2302010, 2106009, 2302050 and 2349 more |
| Date | Jan 21, 2025 |
| 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