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
- Xevonta Dialysator LO 18, Gamma
- 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