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Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system...

FDA Recall #Z-1823-2025 — Class II — April 30, 2025

Recall #Z-1823-2025 Date: April 30, 2025 Classification: Class II Status: Ongoing

Product Description

Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.

Reason for Recall

HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.

Recalling Firm

Maquet Cardiopulmonary Ag — Rastatt, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product 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.

Code Information

Model No. 701045366; UDI 04037691456584; All Serial No.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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