The Recall Desk
HighFDA (Devices)·Z-1371-2016·Announced 2016-04-20

Maquet QUADROX-i oxygenators recalled for potential endotoxin exposure

Maquet Cardiovascular is voluntarily recalling QUADROX-i oxygenators and tubing packs due to a potential risk of endotoxin exposure.

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 high-risk pathogen (endotoxin) in a medical device where the source text describes a 'potential risk' without reporting specific illnesses or injuries, fitting the High severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Maquet Cardiopulmonary (MCP) is conducting a voluntary recall of QUADROX-i oxygenators and custom tubing packs. The recall is being issued due to the potential risk of exposure to endotoxin.

The affected products include all sizes and membrane types of QUADROX-i oxygenators, specifically the QUADROX-i(D) Adult, Small Adult, Pediatric, and Neonatal models with SOFTLINE and BIOLINE Coating. The recall also covers specific tubing packs identified by codes such as BE-HMOD, BEQ-HMO, BEQ-HMOD, BO-VKMO, HMO, HMOD, VKMO, and XVIVO HMO 70100.

A total of 72,000 units were distributed nationwide in the United States. The source text does not specify instructions for consumers or healthcare providers regarding the immediate handling of these devices.

The recalled product

Product
QUADROX-i oxygenators 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 (16)

  • All sizes and membrane types of QUADROX-i oxygenators
  • QUADROX-i(D) Adult
  • Small Adult
  • Pediatric and Neonatal with SOFTLINE and BIOLINE Coating
  • BE-HMOD xxxxx
  • BEQ-HMO xxxxx
  • BEQ-HMOD xxxxx
  • BO-VKMO xxxxx
  • HMO xxxxx
  • HMOD xxxxx
  • VKMO xxxxx
  • X HMO xxxxx U
  • X HMOD 30000 U
  • X VKMO xxxxx U
  • and X 1895. QUADROX-iR with SOFTLINE and BIOLINE Coating
  • XVIVO HMO 70100

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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