Medivators Recalls Hemocor HPH700 Hemoconcentrators Due to Low Ultrafiltration Performance
Medivators, Inc. is recalling 840 Hemocor HPH700 Hemoconcentrators because they may exhibit low ultrafiltration performance below product specifications.
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 is classified as FDA Class II and involves a medical device used during cardiopulmonary bypass. The hazard is a performance defect (low ultrafiltration) that could impact patient care, but the source text does not report specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medivators, Inc. is recalling 840 units of the Hemocor High Performance Hemoconcentrator, model HPH700, sterilized with ethylene oxide. The affected units are from Lot 759491A. The recall was initiated because the devices may exhibit low ultrafiltration performance that is below product specification.
The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed. The recall is classified as Class II by the U.S. Food and Drug Administration.
The affected units were distributed in the United States to the states of California and Michigan. Healthcare facilities and users should stop using the affected devices and contact Medivators, Inc. for further instructions.
The recalled product
- Product
- Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is…
- Manufacturer
- Medivators, Inc.
- Affected units
- 840
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 759491A
Distribution
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