NA HLS Set Advanced 5.0, Small Adult, BIOLINE CoatingRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

3 FDA recall records name this device's identifier, 1 still open.

9 other recalls cover devices cleared under the same FDA submission (K112360); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 22, 2022Open, Classified

   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).

   Z-1765-2022 · Root cause: Package design/selection · FDA record ↗

2. Nov 20, 2020Terminated

   The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.

   Z-0632-2021 · Root cause: Package design/selection · FDA record ↗

3. Nov 20, 2020Terminated

   The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.

   Z-0633-2021 · Root cause: Package design/selection · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112360. One submission often covers many models, so check the product and lot details in each record.

• Z-1077-2024 · Jan 16, 2024 · Open, Classified
  BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
• Z-1076-2024 · Jan 16, 2024 · Open, Classified
  Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
• Z-1188-2023 · Feb 13, 2023 · Open, Classified
  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-connect
• Z-1764-2022 · Jul 22, 2022 · Open, Classified
  BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP Sy
• Z-1767-2022 · Jul 22, 2022 · Open, Classified
  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 Sy
• Z-1766-2022 · Jul 22, 2022 · Open, Classified
  BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP Sy
• Z-2149-2019 · Jul 11, 2019 · Terminated
  Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
• Z-2262-2013 · Aug 15, 2013 · Terminated
  QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracor
• Z-0160-2013 · Jun 12, 2012 · Terminated
  QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for