FDA recall Z-1909-2019

Product

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

US Nationwide Distribution and Internationally to: Canada and Bermuda.

Key facts

Status

Terminated

Initiation date

2019-05-31

Report date

2019-07-10

Termination date

2020-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1909-2019