Product Safety Recalls

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Datascope Corp. Recall 91642

Description: Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

Datascope Corp. Recall 91642 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1232-2023
Event ID91642
Event DescriptionCardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Product TypeDevices
DistributionNationwide US distribution. Worldwide international distribution.
Quantity4502 (US); 4407 (OUS)
Recall ReasonFirm 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.
Device Classification20230315
Device Code InfoModel UDI 0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449 All serialnumbers
Center Classification Date20230306
Recall Initiation Date20230207
Recalling FirmDatascope Corp.
Initial Notification Letter
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