Spectrum Medical Recalls Quantum PureFlow Heat Exchangers Due to Leak Risk
Spectrum Medical SRL is recalling Quantum PureFlow Standard Heat Exchangers because a defect may cause blood to leak into the glycol heat transfer fluid.
What this means for you
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a critical medical device that could lead to significant injury or death if the leak occurs during a procedure.
Plain-English summary
Spectrum Medical SRL is recalling the Quantum PureFlow Standard Heat Exchanger, model HX55V-S0W. The recall is due to a defect that may result in a blood-to-glycol leak within the heat exchanger. This device is a single-use medical component intended to heat or cool blood during cardiopulmonary bypass procedures.
The affected units are identified by Lot Code 18051160302205. A total of 9,448 units were distributed nationwide in the states of Alabama, California, Florida, Kansas, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Wisconsin.
Healthcare facilities and users should stop using the affected heat exchangers immediately and contact Spectrum Medical SRL for instructions on how to return or dispose of the devices. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W Software Version: N/A Product Description: The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler…
- Manufacturer
- SPECTRUM MEDICAL SRL
- Hazard
- Affected units
- 9,448
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 (1)
- Lot Code: 18051160302205 (HX55V-S0W)
Distribution
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