FDA Enforcement
Class II
Ongoing
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Recall: Z-0290-2024
·
Reported November 15, 2023
Enforcement
- Recall Number
- Z-0290-2024
- Event ID
- 93013
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Maquet Medical Systems USA
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 15, 2023
- Initiation Date
- October 12, 2023
- Classification Date
- November 9, 2023
- Address
- 45 Barbour Pond Dr, Wayne, NJ, 07470-2094, United States
Description
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Reason
It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.
Code Info
UDI-DI: 04058863074863; Serial Numbers: 90414355 through 90414868
Distribution
US Nationwide.
Quantity
1022 units