FDA Recalls Heart-Lung Machine Component Over Sterile Barrier Defect
Maquet is recalling an HLS Set Advanced 5.0 component used in CARDIOHELP heart-lung machines due to a compromised sterile barrier that may cause infection. The recall affects 6,657 US units.
What this means for you
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: FDA Class II recall of a medical device component used in critical extracorporeal circulation equipment. No illnesses or injuries have been reported, but the compromised sterile barrier poses substantial risk of serious infection and sepsis. This qualifies as a risk-of-harm product where injury has not yet been manifested.
Plain-English summary
The Emergency Priming Line component of the HLS Set Advanced 5.0 (Product Code/Part Number 70106.9077) used with CARDIOHELP heart-lung machines is being recalled by Maquet Medical Systems USA.
The Emergency Priming Line may have a compromised sterile barrier due to nonconformities at the bag seal. A breached sterile barrier can allow bacterial contamination and may result in inflammation, sepsis, or infection in patients using the equipment.
The recall affects 6,657 units distributed in the United States out of 16,520 units distributed worldwide. Affected lot numbers are: 3000301222, 3000319782, 3000327602, 3000333098, 3000352360, and 3000357174.
Healthcare facilities using affected components should discontinue use immediately and contact Maquet Medical Systems USA for replacement instructions and guidance.
The recalled product
- Product
- Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- sterile-barrier-compromise
- infection-risk
- sepsis-risk
- bacterial-contamination
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 (5)
- UDI-DI 04058863076355 Lots 3000301222
- 3000319782
- 3000327602 ***Added 3/21/24*** 3000333098
- 3000352360
- 3000357174
Distribution
Distributed nationwide across the United States.
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