International safety notice
The manufacturer conducted a periodic mold qualification re-evaluation of the plastic hub portion of the product in March 2021 and made adjustments. However, for product lots manufactured using plastic hubs manufactured after this mold qualification re-evaluation, the procedure We have received reports from the market that the lid of the hub can open inside. I fixed the mold so that the part would not open. Because the possibility cannot be ruled out that the hub lid may open accidentally during the procedure and cease to function normally, We have decided to collect the following items.
Japan / PMDA Recalls · JPN · Oct 7, 2021
Key facts
| Title | The manufacturer conducted a periodic mold qualification re-evaluation of the plastic hub portion of the product in March 2021 and made adjustments. However, for product lots manufactured using plastic hubs manufactured after this mold qualification re-evaluation, the procedure We have received reports from the market that the lid of the hub can open inside. I fixed the mold so that the part would not open. Because the possibility cannot be ruled out that the hub lid may open accidentally during the procedure and cease to function normally, We have decided to collect the following items. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single use needle for tissue production Sales name: Acura Biopsy System |
| Manufacturer | Sugan Co., Ltd. |
| Models | 11385962, 701114090, 11382837, 11383193, 701118090, 11362716, 701120150, 701116090, 11376772, 11366252, 11364350, 11388461 |
| Date | Oct 7, 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