The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1373-2016·Announced 2016-04-20

Maquet Rotaflow Centrifugal Pump Tubing Recalled for Endotoxin Risk

Maquet Cardiovascular is voluntarily recalling Rotaflow Centrifugal Pump custom tubing packs due to a potential risk of endotoxin exposure.

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: The recall involves a high-risk pathogen (endotoxin) in a medical device where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Maquet Cardiopulmonary (MCP) is conducting a voluntary recall of Rotaflow Centrifugal Pump custom tubing packs for the oxygenator. The recall is being conducted due to the potential risk of exposure to endotoxin.

The recall involves 72,000 units in total, which were distributed nationwide in the United States. The affected products are identified by the following codes: BEQ-RF32, BEQ-RF-32-USA, BO-RF-32, BO-RF-32 USA, RF-32, RF-32 USA, and RF-32u.

Healthcare providers and facilities should stop using the affected products and contact the recalling firm for further instructions. The source text does not specify a particular action for individual consumers, as these are medical devices typically used in clinical settings.

The recalled product

Product
Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
Manufacturer
Maquet Cardiovascular Us Sales, Llc
Category
Medical Device — Cardiopulmonary
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 (7)

  • BEQ-RF32
  • BEQ-RF-32-USA
  • BO-RF-32
  • BO-RF-32 USA
  • RF-32
  • RF-32 USA
  • RF-32u.

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 →

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