International safety notice
This product has been certified as a Class II controlled medical device under the general name "Rigid Intubation Laryngoscope". Where necessary, the device was registered as a class I medical device under the general name "laryngoscope for intubation." Therefore, we have decided to voluntarily recall this product.
Japan / PMDA Recalls · JPN · May 20, 2022
Key facts
| Title | This product has been certified as a Class II controlled medical device under the general name "Rigid Intubation Laryngoscope". Where necessary, the device was registered as a class I medical device under the general name "laryngoscope for intubation." Therefore, we have decided to voluntarily recall this product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Intubation laryngoscope Sales name: (1) Airtrack (2) Air track double lumen (3) Air track guideless (4) Air Track Pedi (5) Air Truck Infant (6) Airtrak Avant |
| Manufacturer | Senko Medical Industry Co., Ltd. |
| Models | S20081201, 0023704000, A-200401, N-20040701, I20082401, 80601, S21040601, A210301, A-160501, 0023700801, I-20051201, A-180402 and 49 more |
| Date | May 20, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
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