Cardiohelp HKH 8820 Wall Holder Recall—Mounting Bracket Detachment Risk
The FDA is recalling the Cardiohelp System HKH 8820 Wall Holder mounting bracket because it does not comply with safety standards and has the potential to detach during interhospital transport.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II device recall for a structural defect (non-compliance with DIN EN 1789:20 safety standard) in a mounting bracket used in medical equipment transport. While the potential for detachment poses a risk of harm, no incidents or injuries have been reported. Per the severity rubric, a risk-of-harm product where injury has not yet been reported receives a score of 3 (High).
Plain-English summary
The FDA has issued a recall for the Cardiohelp System HKH 8820 Wall Holder, a mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle. The device does not comply with DIN EN 1789:20 and has the potential to detach.
The recall affects 2 units in the United States (Illinois and Missouri) and 168 units distributed internationally to 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, and Thailand. The affected product is Model Number 701045366 with all serial numbers included in the recall.
The manufacturer, Maquet Cardiopulmonary Ag, is managing this recall.
The recalled product
- Product
- Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
- Manufacturer
- Maquet Cardiopulmonary Ag
- Hazard
- detachment
- structural-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. 701045366
- UDI 04037691456584
- All Serial No.
Distribution
Distributed in 2 states:
- IL
- MO
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