FDAFDA · Food and drugs·Recall number Z-1909-2019
REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Published July 10, 2019 · Recall initiated: May 31, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- US Nationwide Distribution and Internationally to: Canada and Bermuda.
- Lot
- UDI 07332414124076 Lot Numbers: C419205101 C419205201 C419205301
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.