Z-0340-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2023
- Initiation Date
- September 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 units
Product Description
Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
Reason for Recall
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
Model Numbers: MAF-DM2 (04953170407260), MAF-GM (04953170340369), MAF-GM2 (04953170407208), MAF-TM (04953170288630), MAF-TM2 (04953170407147).