FDAClass IIMarch 11, 2020

Revaclear Capillary Dialyzer 300 recall

Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L

Why was Revaclear Capillary Dialyzer 300 recalled?

There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 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?

UDI 07332414123055, Lot Numbers: C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, C419126401

Product
Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Recalling firm
Baxter Healthcare Corporation
Quantity
101976 devices
Distribution
Nationwide
Recall date
March 11, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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