Heater Cooler Unit Recall Due to Potential Bacterial Contamination Risk
Maquet Medical Systems USA is recalling 33 Heater Cooler Unit (HCU 30) devices due to potential water contamination in device circuits that could introduce Mycobacteria or other bacteria. The devices were distributed to nine U.S. states.
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: This Class II device recall involves a high-risk pathogen (Mycobacteria) capable of contaminating internal water circuits in critical medical equipment. No illnesses or injuries have been reported, and the hazard is stated as potential rather than confirmed, placing this at the High severity level per the rubric criteria for untreated high-risk pathogen risks.
Plain-English summary
The U.S. Food and Drug Administration is overseeing a recall of 33 Heater Cooler Unit (HCU 30) devices manufactured by Maquet Medical Systems USA. The HCU 30 supplies temperature-controlled water for use in cardioplegia heat exchangers, blood heat exchangers in extracorporeal circulation, and patient warming and cooling blankets during cardiac surgery procedures.
The recall was issued because of the potential for contaminated water to enter parts of the device's circuits. There is a potential risk of bacterial contamination, including Mycobacteria species, which could pose a health risk to patients who undergo procedures using the affected devices.
The affected devices are identified by model numbers 704629, 705501, and 939001, with all serial numbers of these models affected. The units were distributed to medical facilities in Alabama, California, Florida, Illinois, Kansas, Michigan, Missouri, Nebraska, North Carolina, and Ohio.
Facilities that have received affected units should contact Maquet Medical Systems USA regarding the appropriate response to this recall.
The recalled product
- Product
- Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.
- Manufacturer
- Maquet Medical Systems USA
- Affected units
- 33
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 70103.4653HCU 30 Base Unit 200-240 V
- Model Number 939001 I 70102.8718 All serial numbers are affected.
Distribution
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