Maquet Medical Systems USA Recall 91569
Description: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.
Maquet Medical Systems USA Recall 91569 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1188-2023 |
| Event ID | 91569 |
| Event Description | BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czechia, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritius, Myanmar, Mexico, Moldova, Morocco, Namibia, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of North Macedonia, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, The Republic of Korea, The Russian Federation, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Vietnam. |
| Quantity | 10,587 units (US); 94,987 (worldwide) |
| Recall Reason | 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. |
| Device Classification | 20230308 |
| Device Code Info | 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 |
| Center Classification Date | 20230228 |
| Recall Initiation Date | 20230213 |
| Recalling Firm | Maquet Medical Systems USA |
| Initial Notification | Letter |
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