GAMBRO Capillary Dialyzer recall: Particulate Matter
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device…
Why was GAMBRO Capillary Dialyzer recalled?
Potential presence of particulate matter on the blood side of the dialyzer
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?
C416201601
- Product
- GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device…
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 22,656 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.
- Recall date
- November 16, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)