Reported Mar 8, 2023 · Ongoing
BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code…
Maquet Medical Systems USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
3 of 3 products
| Model / number | Product as published |
|---|---|
| — | BEQ-HLS 5050 USA |
70106.9077 | HLS Set Advanced 5.0, , BEQ-HLS 7050 USA |
70106.9078. | HLS Set Advanced 7.0, Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support. |
- Lot codes and dates
- HLS Set Advanced 5.0, Product Code 70106.9077 UDI-DI 04058863076355 HLS Set Advanced 7.0, Product Code 70106.9078 UDI-DI 04058863080383 All lots/batches affected
- Amount recalled
- 10,587 units (US); 94,987 (worldwide)
Where it was sold
- Nationwide
Why it was recalled
Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.
This product could cause temporary or reversible health problems — stop using it.
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