International safety notice
In the specific lot numbers of "PCCO Monitoring Kit II" and "ProAQT Sensor" manufactured and sold by our company, It was found that sterility could be compromised due to poor sealing. Overseas manufacturer Prussion Medical Systems, Inc. has received no complaints of adverse events related to defects in its sterile barrier system. However, since we cannot guarantee the sterility of this product in this lot, we have decided to initiate a voluntary recall. It has been decided.
Japan / PMDA Recalls · JPN · Feb 10, 2022
Key facts
| Title | In the specific lot numbers of "PCCO Monitoring Kit II" and "ProAQT Sensor" manufactured and sold by our company, It was found that sterility could be compromised due to poor sealing. Overseas manufacturer Prussion Medical Systems, Inc. has received no complaints of adverse events related to defects in its sterile barrier system. However, since we cannot guarantee the sterility of this product in this lot, we have decided to initiate a voluntary recall. It has been decided. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Single Use Pressure Transducer Brand name: (1)PCCO Monitoring Kit II (2) ProAQT sensor |
| Manufacturer | Getinge Group Japan Co., Ltd. |
| Models | 21CB01, 21BB01, 6882817, 6882824, 21BD01, 21BC01 |
| Date | Feb 10, 2022 |
| 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