The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0348-2017·Announced 2016-11-09

Maquet HCU 30 Heater-Cooler Units Recalled for Bacterial Contamination Risk

Maquet Cardiovascular is recalling 305 HCU 30 units because contaminated water, including Mycobacteria, may enter the device circuits.

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 (Mycobacteria) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling 305 units of the HCU 30 Heater-Cooler Unit. These devices are used to supply temperature-controlled water for cardioplegia heat exchangers, blood heat exchangers in extra-corporeal circulation, and patient warming or cooling blankets during short-duration cardiopulmonary bypass procedures.

The recall is issued because there is a potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. This creates a potential risk of bacterial contamination, including Mycobacteria species.

The affected units are the HCU 30 Base Unit 100-120 V (Model 704629), HCU 30 Base Unit Canadian/US (Model 705501), and HCU 30 Base Unit 200-240 V (Model 939001). All serial numbers for these models are affected. The units were distributed worldwide and nationwide in the US.

The recalled product

Product
Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended…
Manufacturer
Maquet Cardiovascular Us Sales, Llc
Category
Medical Device — Cardiovascular
Hazard
Affected units
305

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 (4)

  • HCU 30 Base Unit 100-120 V
  • Model Number 704629 I 70103.4371 HCU 30 Base Unit Canadian/US
  • Model Number 705501 I 70103.4653 HCU 30 Base Unit 200-240 V
  • Model Number 939001 I 70102.8718 All serial numbers are affected.

Distribution

Distributed nationwide across the United States.

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