Medical Device Recall: Heart-Lung Machine Component Sterile Barrier Defect
The BEQ-HLS 7050 USA HLS Set Advanced 7.0 is recalled due to a compromised sterile barrier on its Emergency Priming Line component. This defect may cause inflammation, sepsis, or infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device with serious potential hazards (sepsis and infection from a compromised sterile barrier) but no reported illnesses or injuries mentioned in the source. It qualifies as a risk-of-harm product where injury has not yet been reported, meeting the Score 3 (High) criterion.
Plain-English summary
The BEQ-HLS 7050 USA HLS Set Advanced 7.0 (Product Code/Part Number 70106.9078) is a component used with the CARDIOHELP heart-lung machine. The Emergency Priming Line within this set has been found to have a compromised sterile barrier due to nonconformities at the bag seal.
This sterile barrier compromise may result in inflammation, sepsis, or infection when the component is used in patient care.
The recall affects approximately 16,520 units worldwide, with 6,657 units distributed in the United States. Affected units are identified by UDI-DI 04058863080383 and specific lot numbers documented in the FDA recall notice.
The recalled product
- Product
- BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
- Manufacturer
- Maquet Medical Systems USA
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI 04058863080383 Lots 3000280906
- 3000280907
- 3000280908
- 3000280909
- 3000282253
- 3000282254
- 3000282255
- 3000291127
- 3000300688
- 3000314506
- 3000316206
- 3000316600
- 3000317531
- 3000317532
- 3000318850
- 3000318851
- 3000318852
- 3000318853
- 3000319748
- 3000319749
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Maquet Medical Systems USA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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