Recall Z-1823-2025— Maquet Cardiopulmonary Ag
Class II · Ongoing
Class II FDA medical device recall by Maquet Cardiopulmonary Ag, initiated 2025-04-30. It names one FDA 510(k) clearance: K102726. Product: Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.. Reason: HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach..
- Recalling firm
- Maquet Cardiopulmonary Ag
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-30
- Firm location
- Rastatt, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.