Cardiohelp System HKH 8820 Wall Holder Mounting Bracket Recall
The Cardiohelp System HKH 8820 Wall Holder, a mounting bracket for the CARDIOHELP-i system used in interhospital transport, does not comply with standard DIN EN 1789:20 and may detach during use.
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: The source indicates an FDA Class II recall with a non-compliance issue (failure to meet safety standard DIN EN 1789:20) and potential for detachment of a mounting bracket used in critical patient transport. No reported illnesses or injuries are mentioned, but this is a risk-of-harm product where injury has not yet been reported, meeting the High (score 3) threshold.
Plain-English summary
Maquet Cardiopulmonary Ag is recalling the Cardiohelp System HKH 8820 Wall Holder (Model No. 701045366, UDI 04037691456584, all serial numbers). This mounting bracket is designed to hold the CARDIOHELP-i system during interhospital transport by vehicle.
The wall holder does not comply with standard DIN EN 1789:20 and has the potential to detach. This non-compliance poses a risk during transport of critical cardiopulmonary support equipment.
Two units were distributed in the United States (Illinois and Missouri). An additional 168 units were 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.
Customers who have received this product should contact Maquet Cardiopulmonary Ag or their local distributor for instructions on inspection, replacement, or return of the wall holder.
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
- equipment-detachment
- non-compliance-safety-standard
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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