Product Safety Recalls

Product Recall Tracker

Datascope Corp. Recall 88983

Description: Cardiosave Rescue Model UDI 0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449

Datascope Corp. Recall 88983 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0337-2022
Event ID88983
Event DescriptionCardiosave Rescue Model UDI 0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449
Product TypeDevices
DistributionWorldwide distribution - US Nationwide.
Quantity4,338 (US); 3,613 (OUS)
Recall ReasonFirm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
Device Classification20211222
Device Code InfoAll Unit Serial Numbers
Center Classification Date20211215
Recall Initiation Date20211115
Recalling FirmDatascope Corp.
Initial Notification Letter
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.