Spectrum Medical Quantum Standard Heat Exchanger Sterilization Defect Recall
QURA S.R.L. is recalling 1088 units of Spectrum Medical Quantum Standard heat exchangers that may not be adequately sterilized. The devices also lack required 510(k) clearance for US distribution.
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 Class II medical device with a sterilization defect, which presents a risk of pathogenic contamination in clinical use. However, no illnesses or injuries have been reported. Per the rubric, absence of reported adverse events limits the score to a maximum of 3.
Plain-English summary
Spectrum Medical Quantum Standard heat exchangers manufactured by QURA S.R.L. are being recalled due to sterilization deficiencies. The devices are labeled as sterile but may not have been adequately sterilized during manufacturing.
Approximately 1088 units were distributed nationwide in South Carolina. The affected devices are identified by batch numbers B000129, C000415, C000416, and C000417.
Additionally, these devices were imported to the US distributor without obtaining required FDA 510(k) clearance. Consumers in possession of affected units should contact the recalling manufacturer, QURA S.R.L., for instructions on return or device management.
The recalled product
- Product
- Spectrum Medical Quantum Standard heat exchanger
- Manufacturer
- QURA S.R.L.
- Category
- Medical Device — Heat Exchanger
- Affected units
- 1,088
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)
- Batch Numbers: B000129
- C000415
- C000416
- C000417
Distribution
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