Cardiohelp System HKH 8820 Wall Holder. Mounting recall
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Why was Cardiohelp System HKH 8820 Wall Holder. Mounting recalled?
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No. 701045366; UDI 04037691456584; All Serial No.
- Product
- Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
- Recalling firm
- Maquet Cardiopulmonary Ag
- Quantity
- US: 2 units; OUS: 168 units
- 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.
- Recall date
- June 4, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)