CLASS II ONGOING Device recall · Reported 21 Feb 2024 · FDA Enforcement Report
Model No. Beq-hls 5050 USA, HLS Set Advanced 5.0, Product Code/Part recalled
Maquet Medical Systems USA is recalling Model No. Beq-hls 5050 USA, HLS Set Advanced 5.0, Product Code/Part, distributed nationwide in the US. The recall was initiated on 16 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1076-2024
- FDA event ID
- 93849
- Recalling firm
- Maquet Medical Systems USA, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Jan 2024
- FDA classified
- 13 Feb 2024
- Reported
- 21 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 16 Jan 2024 | Recall initiated by company | |
| 13 Feb 2024 | Classified by FDA | +28 days |
| 21 Feb 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Why was it recalled?
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Which lots are affected?
UDI-DI 04058863076355 Lots 3000301222, 3000319782, 3000327602 ***Added 3/21/24*** 3000333098, 3000352360, 3000357174
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93849This product is part of a recall event; the main page for the event is Beq-hls 7050 USA, HLS Set Advanced 7.0, Product recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Beq-hls 7050 USA, HLS Set Advanced 7.0, Product recalled | Maquet Medical Systems USA | Sterility | Nationwide |
More recalls from Maquet Medical Systems USA
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cardiohelp-i System recalled by Maquet Medical Systems U | Maquet Medical Systems USA | Packaging Defects | Nationwide |
| Device | CLASS II | Beq-hls 7050 USA, HLS Set Advanced 7.0, Product recalled | Maquet Medical Systems USA | Sterility | Nationwide |
| Device | CLASS II | Beq-rf-32-Usa RotaFlow Centrifugal Pump recalled | Maquet Medical Systems USA | Sterility | Nationwide |
| Device | CLASS II | Bo-rf-32-Usa RotaFlow Centrifugal Pump recalled | Maquet Medical Systems USA | Sterility | Nationwide |
| Device | CLASS II | Bubble Sensor recalled by Maquet Medical Systems U | Maquet Medical Systems USA | Device Malfunction | 13 states |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |