REVACLEAR 400 Dialyzer recall
REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure…
Why was REVACLEAR 400 Dialyzer recalled?
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
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 07332414124076 Lot Numbers: C419205101 C419205201 C419205301
- Product
- REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 65403 units
- Distribution
- US Nationwide Distribution and Internationally to: Canada and Bermuda.
- Recall date
- July 10, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)