FDA Device recall Z-1690-2015
HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configurat…
- FDA Device
- Class II
- terminated
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class II recall of HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configurat… by Maquet Cardiovascular Us Sales, citing A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1690-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-05 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Maquet Cardiovascular Us Sales |
| Distribution | US |
Product
HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport. Due to its system combination of integrated oxygenator and centrifugal pump, the HLS Set Advanced is suitable for both extracorporeal pulmonary support and cardiovascular support, and for simultaneous cardiovascular and pulmonary support.
Reason
A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.
Identifiers
| code_info | Part numbers BEQ-HLS 5050, 70105,2797, BEQ-HLS 7050, 70105.2794, and BO-HLS 7050, 70105.2786 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1690-2015%22
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