International safety notice
During the ethylene oxide gas sterilization of the product, a biological indicator (BI) error occurred in some operations. It turned out that the judgment was not made properly. Since the risk of infection to patients cannot be denied because the product has not been confirmed to be harmful to patients, we are taking every precaution to We will collect the items voluntarily. In addition, we checked all records of products manufactured in the past three years (from 2018 onwards), which is the sterilization effective period, and found that there were no similar incidents. As we have confirmed that this is the case, we are voluntarily recalling only the product in question.
Japan / PMDA Recalls · JPN · Jun 7, 2021
Key facts
| Title | During the ethylene oxide gas sterilization of the product, a biological indicator (BI) error occurred in some operations. It turned out that the judgment was not made properly. Since the risk of infection to patients cannot be denied because the product has not been confirmed to be harmful to patients, we are taking every precaution to We will collect the items voluntarily. In addition, we checked all records of products manufactured in the past three years (from 2018 onwards), which is the sterilization effective period, and found that there were no similar incidents. As we have confirmed that this is the case, we are voluntarily recalling only the product in question. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Names: (1) Single Use General Purpose Surgical Drape (2) Single Use Class III Procedure Kit Sales name: (1) Drape (2) Angio kit |
| Manufacturer | Kawamoto Sangyo Co., Ltd. |
| Models | 028-112170-12, 027-109510-00, 028-101306-04, 028-113803-03, 028-112193-03, 028-101346-07, 028-101299-03, 028-112307-05, 210506, 028-101491-03, 028-100910-04, 028-101641-00 and 1 more |
| Date | Jun 7, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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