International safety notice
During the domestic acceptance inspection of the products in question, a leak was discovered in some of the seals on the sterile packaging. Regarding products, we cannot completely deny the possibility that sterility cannot be guaranteed, and in the unlikely event that such an event occurs, In order to prevent potential health hazards, we have decided to implement a voluntary recall of the affected lots. Ta.
Japan / PMDA Recalls · JPN · Aug 25, 2021
Key facts
| Title | During the domestic acceptance inspection of the products in question, a leak was discovered in some of the seals on the sterile packaging. Regarding products, we cannot completely deny the possibility that sterility cannot be guaranteed, and in the unlikely event that such an event occurs, In order to prevent potential health hazards, we have decided to implement a voluntary recall of the affected lots. Ta. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single use general purpose surgical drape Brand name: Sterilized surgical nonwoven products |
| Manufacturer | Medline Japan LLC |
| Models | ZS-PS401, 21CAH001 |
| Date | Aug 25, 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