Home / Recalls / Baxter Healthcare Corporation / Z-1909-2019

Z-1909-2019 Class II Terminated

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
July 10, 2019
Initiation Date
May 31, 2019
Termination Date
October 5, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
65403 units

Product Description

REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.

Reason for Recall

There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

Distribution Pattern

US Nationwide Distribution and Internationally to: Canada and Bermuda.

Code Information

UDI 07332414124076 Lot Numbers: C419205101 C419205201 C419205301

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