International safety notice
This product is made of non-natural rubber (latex free) used in surgery to protect patients and users from cross-infection. -) surgical gloves. We received a report from a medical institution that gloves labeled as made of natural rubber were found in individual packaging. As a result of an investigation by an overseas manufacturing facility, it was found that in a specific lot of the individual packaging production line, natural It was discovered that rubber (latex) surgical gloves had been mixed in and the product had been mistakenly packaged in latex-free packaging. Therefore, we have decided to voluntarily recall all products with the affected lot numbers.
Japan / PMDA Recalls · JPN · Dec 22, 2021
Key facts
| Title | This product is made of non-natural rubber (latex free) used in surgery to protect patients and users from cross-infection. -) surgical gloves. We received a report from a medical institution that gloves labeled as made of natural rubber were found in individual packaging. As a result of an investigation by an overseas manufacturing facility, it was found that in a specific lot of the individual packaging production line, natural It was discovered that rubber (latex) surgical gloves had been mixed in and the product had been mistakenly packaged in latex-free packaging. Therefore, we have decided to voluntarily recall all products with the affected lot numbers. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Non-natural rubber surgical gloves Sales name: GAMMEX latex-free surgical gloves NP |
| Manufacturer | Nipro Co., Ltd. |
| Models | 2108490804, 20-629 |
| Date | Dec 22, 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