International safety notice
Display of the secondary packaging (unit box of 30 pieces) of the target product (product number: 28514, product name: Speedy Kateneraton 20) It turned out that there was an error. There are three labels affixed to the secondary packaging, one of which is labeled with a different size item (product number: 2861). 2. A label with the product name Speedy Cateneraton 30) was attached. We are voluntarily recalling the product because an error occurred in the size display indicating the product name, outer diameter, and overall length. <Correct display> Product number: 28514 Product name: Speedy Kate Neraton 20 Size: CH/FR 14/4.7mm <Incorrect display> Product number: 28612 Product name: Speedy Cate Neraton 30 Size: CH/FR 12/4.0mm
Japan / PMDA Recalls · JPN · May 9, 2023
Key facts
| Title | Display of the secondary packaging (unit box of 30 pieces) of the target product (product number: 28514, product name: Speedy Kateneraton 20) It turned out that there was an error. There are three labels affixed to the secondary packaging, one of which is labeled with a different size item (product number: 2861). 2. A label with the product name Speedy Cateneraton 30) was attached. We are voluntarily recalling the product because an error occurred in the size display indicating the product name, outer diameter, and overall length. <Correct display> Product number: 28514 Product name: Speedy Kate Neraton 20 Size: CH/FR 14/4.7mm <Incorrect display> Product number: 28612 Product name: Speedy Cate Neraton 30 Size: CH/FR 12/4.0mm |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Intermittent urinary catheter Sales name: Speedy Cate |
| Manufacturer | Coloplast Co., Ltd. |
| Models | 8818153 |
| Date | May 9, 2023 |
| 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