Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Sli
Summary
The FDA issued a Class II for Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers by Maquet Medical Systems USA. 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.
Details
Source
Device Recall
External ID
Z-0290-2024
Action Date
2023-11-15
Status
Ongoing
Category
device
Product Description
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
Lot/Code Info: UDI-DI: 04058863074863; Serial Numbers: 90414355 through 90414868
Quantity Affected: 1022 units
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.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-12
Company
Wayne, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Maquet Medical Systems USA has 36 FDA actions in our database, including 36 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Maquet Medical Systems USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Maquet Medical Systems USA have FDA actions?
Maquet Medical Systems USA has 36 FDA actions in our database, including 36 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0290-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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