Cardiosave Rescue recall
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Why was Cardiosave Rescue recalled?
Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
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 Number: 0998-00-0800-83. UDI-DI: 10607567108407. All serial numbers.
- Product
- Cardiosave Rescue. Model Number: 0998-00-0800-83.
- Recalling firm
- Datascope Corp.
- Quantity
- 47 units (44 US, 3 OUS)
- Distribution
- Nationwide US distribution. Worldwide international distribution.
- Recall date
- March 15, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)