Fresenius Service Replacement 0-Ring. Used in as a recall
Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines…
Why was Fresenius Service Replacement 0-Ring. Used in as a recalled?
Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: 640919
- Product
- Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines…
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 725 units
- Distribution
- Nationwide Distribution including the states of AR, CA, FL, GA, KY, LA, MA, MD, NC, NJ, NY, PA, PR, SC, TX and VA.
- Recall date
- July 17, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)