International safety notice
We have received information that the information on the label on the product box and the product enclosed are different. Blade #1 for infants" (Catalog number: 69061, Serial number: 21-056) is displayed on the product box, which is different from what is displayed. It turned out that "Macintosh Blade #2 Pediatric Use" (Catalog Number: 69062) was included. "Macintosh Blade #1 for infants" and "Macintosh Blade #2 for children" have the same purpose. The products used differ in blade length. "Macintosh Blade #1 for infants": Total length 89mm "Macintosh Blade #2 Pediatric": Total length 108mm As a result of an investigation, it was confirmed that the product was mistakenly packaged in a product that was different from what was displayed on the product box during manufacturing. We have decided to voluntarily recall this product (catalog number: 69061). 69061 is also included in the "Macintosh Blade LED Laryngoscope Set" (Catalog Number: 69696-LED). 69696-LED may also contain a product that is different from what is displayed on the product box, so we are issuing a voluntary recall for 69696-LED as well. Decided.
Japan / PMDA Recalls · JPN · Jun 24, 2022
Key facts
| Title | We have received information that the information on the label on the product box and the product enclosed are different. Blade #1 for infants" (Catalog number: 69061, Serial number: 21-056) is displayed on the product box, which is different from what is displayed. It turned out that "Macintosh Blade #2 Pediatric Use" (Catalog Number: 69062) was included. "Macintosh Blade #1 for infants" and "Macintosh Blade #2 for children" have the same purpose. The products used differ in blade length. "Macintosh Blade #1 for infants": Total length 89mm "Macintosh Blade #2 Pediatric": Total length 108mm As a result of an investigation, it was confirmed that the product was mistakenly packaged in a product that was different from what was displayed on the product box during manufacturing. We have decided to voluntarily recall this product (catalog number: 69061). 69061 is also included in the "Macintosh Blade LED Laryngoscope Set" (Catalog Number: 69696-LED). 69696-LED may also contain a product that is different from what is displayed on the product box, so we are issuing a voluntary recall for 69696-LED as well. Decided. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Intubation laryngoscope Brand name: Welch-Allen laryngoscope |
| Manufacturer | Welch Allen Japan Co., Ltd. |
| Models | 69061, 21-119, 69696-LED, 21-341, 22-089, 21-210, 21-084, 21-056 |
| Date | Jun 24, 2022 |
| 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