Maquet Cardiopulmonary Ag: Device Recall
Recall #Z-1823-2025 · 04/30/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1823-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Maquet Cardiopulmonary Ag
- Status
- Ongoing
- Date Initiated
- 04/30/2025
- Location
- Rastatt, N/A, Germany
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 2 units; OUS: 168 units
Reason for Recall
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
Product Description
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Distribution Pattern
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.