Fresenius Hemoflow F3 Dialyzer Recalled for Potential Header Leak
Fresenius Medical Care is recalling 1,650 Hemoflow F3 Dialyzers due to a potential header leak caused by improper torque.
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 medical device with a functional defect (leak) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 1,650 units of the Fresenius Hemoflow F3 Dialyzer, Part Number 0520165A. The product is indicated for acute and chronic hemodialysis. The recall is due to a potential header leak resulting from possible improper torque.
The affected units are identified by Lot Number 15KU04011 and have an expiration date of 08/31/2013. These dialyzers were distributed nationwide in the United States, including the states of Arizona, California, Connecticut, Georgia, Illinois, Indiana, Michigan, Minnesota, Missouri, Mississippi, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Texas, and Washington, as well as the District of Columbia.
Consumers and healthcare providers should stop using the affected dialyzers and contact the recalling firm for further instructions or a replacement.
The recalled product
- Product
- Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis
- Hazard
- Affected units
- 1,650
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 Number: 15KU04011 Exp. Date : 08/31/2013
Distribution
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