Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Reported: November 15, 2023 Initiated: October 12, 2023 #Z-0290-2024
Product Description
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Reason for Recall
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.
Details
- Recalling Firm
- Maquet Medical Systems USA
- Units Affected
- 1022 units
- Distribution
- US Nationwide.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder). Recalled by Maquet Medical Systems USA. Units affected: 1022 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 15, 2023. Severity: Moderate. Recall number: Z-0290-2024.
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