Mobile airway scope-diagnosis and observation to access recall: Contamination
Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2…
Why was Mobile airway scope-diagnosis and observation to access recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Numbers: MAF-DM2 (04953170407260), MAF-GM (04953170340369), MAF-GM2 (04953170407208), MAF-TM (04953170288630), MAF-TM2 (04953170407147).
- Product
- Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2…
- Recalling firm
- Aizu Olympus Co., Ltd.
- Quantity
- 33 units
- Distribution
- Worldwide - US Nationwide distribution.
- Recall date
- November 29, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)