Polyflux Revaclear recall
Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure…
Why was Polyflux Revaclear recalled?
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
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?
Lot Numbers: C413124101, C413124301, C413124501, C413124601, C413124701, C413124801, C413124901, C413125001, C413125101, C413125201, C413125301, C413125401, C413125501, C413125601, C413125701, C413125801, C413125901, C413126001, C413126101, C413126201, C413126301, C413126401, C413126501, C413126601, C413126701, C413126801, C413126901, C413127001, C413127101, C413127201, C413127301, C413127401, C413127501, C413127601, C413127701, C413127801, C413127901, C413128001, C413128101, C413128201, C413128401, C413128501, C413128601, C413128701, C413128801, C413128901, C413129001, C413129101, C413129201, C413129301, C413129401, C413129501, C413129601, C414100101, C414100601, C414101001, C414101201, C414101401, C414102101, C414102301, C414103001, C414103401, C414103501, and C414103801.
- Product
- Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure…
- Recalling firm
- Gambro Renal Products, Incorporated
- Quantity
- 2,461,824 units total
- Distribution
- Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.
- Recall date
- May 28, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)