Cardiosave Rescue. Model Number: 0998-00-0800-83.
Reported: March 15, 2023 Initiated: February 7, 2023 #Z-1232-2023
Product Description
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Reason for Recall
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.
Details
- Recalling Firm
- Datascope Corp.
- Units Affected
- 47 units (44 US, 3 OUS)
- Distribution
- Nationwide US distribution. Worldwide international distribution.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
Cardiosave Rescue. Model Number: 0998-00-0800-83.. Recalled by Datascope Corp.. Units affected: 47 units (44 US, 3 OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 15, 2023. Severity: Moderate. Recall number: Z-1232-2023.
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