Reported Dec 27, 2023 · Ongoing
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through…
Maquet Medical Systems USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Medical Systems USA · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- CARDIOHELP-i Heart Lung Support SystemBlood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours)
- Product REF Numbers
701072780701048012
- Lot codes and dates
- UDI-DI04058863074863; 04037691658384 All serial numbers up to and including 90415172
- Amount recalled
- 1594 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
CARDIOHELP-i System was not properly tested to measure leakage current
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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