Recall archive / FDA device enforcement
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory an... — FDA record Z-1767-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 22, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
- Reason
- The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
- Classification
- Class II
- Recalling firm
- Maquet Medical Systems USA
- Quantity
- 6,871 US; 18,670 worldwide
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1767-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 04058863080383 Lots 3000190535, 3000190536, 3000190537, 3000192076, 3000192077, 3000192078, 3000192079, 3000193358, 3000193359, 3000193360, 3000193361, 3000193362, 3000195061, 3000195062, 3000195063, 3000195064, 3000195065, 3000195066, 3000195067, 3000196193, 3000196195, 3000196196, 3000196197, 3000196198, 3000196199, 3000197830, 3000197831, 3000197833, 3000197837, 3000197839, 3000199069, 3000199071, 3000199072, 3000199073, 3000199074, 3000199077, 3000200108, 3000200110, 3000200111, 3000200112, 3000200113, 3000202025, 3000202027, 3000202029, 3000202030, 3000202031, 3000203092, 3000203093, 3000204058, 3000204156, 3000204157, 3000204284, 3000205878, 3000205879, 3000205880, 3000207510, 3000208687, 3000208692, 3000210629, 3000210630, 3000215200, 3000215238, 3000216174, 3000216177, 3000220057, 3000220062, 3000221755, 3000221756, 3000221757, 3000224126, 3000224134, 3000227577, 3000227580, 3000228336, 3000228337, 3000228338, 3000228804, 3000228805, 3000228864, 3000232543, 3000234522 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries Canada and Australia.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 28, 2022
- Recall initiation date
- Jul 22, 2022
- Center classification date
- Sep 19, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.