The Recall Desk
HighFDA (Devices)·Z-1372-2016·Announced 2016-04-20

Maquet Recalls HLS Set Advanced Oxygenator Tubing Packs Due to Endotoxin Risk

Maquet Cardiovascular is voluntarily recalling HLS Set Advanced oxygenator tubing packs due to a potential risk of exposure to endotoxin.

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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria for potential exposure to endotoxin without confirmed illness.

Plain-English summary

Maquet Cardiopulmonary (MCP) is conducting a voluntary recall of HLS Set Advanced with BIOLINE Coating custom tubing packs for the oxygenator. The recall is being conducted based on the potential risk of exposure to endotoxin for various products.

The affected products include the Small Adult 5.0 with BIOLINE Coating (BEQ-HLS 5050, 70105.2797), Adult 7.0 with BIOLINE Coating (BEQ-HLS 7050, 70105.2794), and Adult 7.0 with SOFTLINE Coating (BO-HLS 7050, 70105.2786). A total of 72,000 units were distributed nationwide in the United States.

Healthcare providers and facilities should contact Maquet Cardiovascular for instructions on how to handle the recalled products. The source text does not specify specific actions for consumers, as these are medical devices used in clinical settings.

The recalled product

Product
HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
Manufacturer
Maquet Cardiovascular Us Sales, Llc
Category
Medical Device — Cardiopulmonary / Oxygenator
Hazard
Affected units
72,000

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)

  • HLS Set Advanced: Small Adult 5.0 with BIOLINE Coating BEQ-HLS 5050
  • 70105.2797
  • Adult 7.0 with BIOLINE Coating BEQ-HLS 7050
  • 70105.2794 and Adult 7.0 with SOFTLINE Coating BO-HLS 7050
  • 70105.2786

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Maquet Cardiovascular Us Sales, Llc 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 4 products in this recall →

Related recalls

Same manufacturer · Maquet Cardiovascular Us Sales, Llc

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Same hazard · endotoxin exposure

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