REVACLEAR Dialyzer (2019-05-29)

Starting date:

May 29, 2019

Posting date:

June 21, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70233

Last updated: 2019-06-21

• 
  Reason
• 
  Affected products

Affected Products

REVACLEAR Dialyzer

Reason

Baxter Corporation is issuing a voluntary product recall for REVACLEAR dialyzers due to the potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment. The affected lots were distributed by Baxter canada between 4/22/2019 and 5/21/2019. Blood leaks within the dialyzer may lead to delay in therapy and blood loss equivalent to the extracorporeal circuit. This is expected to result in negligible harm in the majority of patients.

Affected products