Carina Sub-Acute Care Ventilator recall
Carina Sub-Acute Care Ventilator
Why was Carina Sub-Acute Care Ventilator recalled?
Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed the acceptable uptake level during continuous use (>30 days) in pediatric patients.
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?
Part No. 5704110; UDI-DI 04048675398516; All Serial No.
- Product
- Carina Sub-Acute Care Ventilator
- Recalling firm
- Draeger Medical, Inc.
- Quantity
- 11,621 units
- Distribution
- US Nationwide Distribution.
- Recall date
- August 30, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)