International safety notice
Some lots (Lot 3000000028) of "Quantra QPlus Cartridge" from the American manufacturer Hemosonics. hand, We received a notification that some of the measured values may be abnormal and will be recalled. of quality We have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · May 31, 2021
Key facts
| Title | Some lots (Lot 3000000028) of "Quantra QPlus Cartridge" from the American manufacturer Hemosonics. hand, We received a notification that some of the measured values may be abnormal and will be recalled. of quality We have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Manufacturer | Heiwa Bussan Co., Ltd. |
| Models | KT-0010, 3000000028 |
| Date | May 31, 2021 |
| 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