Spectrum Medical Recalls Quantum PureFlow Heat Exchangers Due to Leak Risk
Spectrum Medical SRL is recalling Quantum PureFlow Standard Heat Exchangers due to a risk of blood-to-glycol leaks during cardiopulmonary bypass procedures.
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 (blood-to-glycol leak) in a critical medical device used during surgery, which poses a significant risk of serious injury.
Plain-English summary
Spectrum Medical SRL is recalling the Quantum PureFlow Standard Heat Exchanger, Model HX55W-S0. The recall is due to a potential blood-to-glycol leak in the heat exchanger. This device is a single-use medical component intended to heat or cool blood during routine cardiopulmonary bypass (CPB) procedures.
The affected 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. The specific lot code for the recalled units is 18051160301178.
Healthcare facilities and users should stop using the affected heat exchangers immediately. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Catalog Number: HX55W-S0 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
- Affected units
- 3,232
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: 18051160301178 (HX55W-S0)
Distribution
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