Health product recall

Xevonta Dialysator LO & HI 18, Gamma (2020-05-06)

Starting date:
May 6, 2020
Posting date:
May 29, 2020
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-73197

Last updated: 2020-05-29

Affected Products

  1. Xevonta Dialysator LO 18, Gamma
  2. Xevonta Dialysator HI 18, Gamma

Reason

There are occasional leakages at one of the blood caps of the recalled dialysers.  The leakage is located between housing and blood cap of the dialyser due to a deviation in the production process.

Affected products

A. Xevonta Dialysator LO 18, Gamma

Lot or serial number

Batch # 140120120

Model or catalog number

7204550

Companies
Manufacturer
B. Braun Avitum Ag
Schwarzenberger Weg 73-79
Melsungen
34212
GERMANY

B. Xevonta Dialysator HI 18, Gamma

Lot or serial number
  • Batch # 140130120
  • Batch # 140200220
  • Batch # 140260220
Model or catalog number

7204657

Companies
Manufacturer
B. Braun Avitum Ag
Schwarzenberger Weg 73-79
Melsungen
34212
GERMANY