FDA Enforcement
Class II
Ongoing
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Recall: Z-1823-2025
·
Reported June 4, 2025
Enforcement
- Recall Number
- Z-1823-2025
- Event ID
- 96820
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Maquet Cardiopulmonary Ag
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 4, 2025
- Initiation Date
- April 30, 2025
- Classification Date
- May 27, 2025
- Address
- Kehler Str. 31, N/A, Rastatt, N/A, N/A, Germany
Description
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Reason
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
Code Info
Model No. 701045366; UDI 04037691456584; All Serial No.
Distribution
Domestic: IL & MO. Foreign: Australia, Austria, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, South Korea, Poland, Russia, Saudi Arabia, Spain, Switzerland, Thailand.
Quantity
US: 2 units; OUS: 168 units