EVODIAL 1.3, 1.6, 2.2 and NEPHRAL ST 300, NEPHRAL ST 400, NEPHRAL ST 500 (2019-05-15)
- Starting date:
- May 15, 2019
- Posting date:
- May 31, 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-70073
Last updated: 2019-05-31
Affected Products
- EVODIAL 1.3
- EVODIAL 1.6
- EVODIAL 2.2
- NEPHRAL ST 300, NEPHRAL ST 400, NEPHRAL ST 500
Reason
Baxter is taking this action as a precautionary measure as these dialyzers were potentially exposed to temperatures below 0 degrees celsius during shipment to canada. There may be a potential for internal blood leakages (IBLS) to occur during therapy with the use of these affected dialyzers.
Affected products
A. EVODIAL 1.3
Lot or serial number
18G2306
Model or catalog number
1.3
Companies
- Manufacturer
-
Gambro Industries
7 Avenue Lionel Terray, B.P. 126
Meyzieu
69883
FRANCE
B. EVODIAL 1.6
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
1.6
Companies
- Manufacturer
-
Gambro Industries
7 Avenue Lionel Terray, B.P. 126
Meyzieu
69883
FRANCE
C. EVODIAL 2.2
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
2.2
Companies
- Manufacturer
-
Gambro Industries
7 Avenue Lionel Terray, B.P. 126
Meyzieu
69883
FRANCE
D. NEPHRAL ST 300, NEPHRAL ST 400, NEPHRAL ST 500
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- NEPHRAL ST 300
- NEPHRAL ST 400
- NEPHRAL ST 500
Companies
- Manufacturer
-
Gambro Industries
7 Avenue Lionel Terray, B.P. 126
Meyzieu
69883
FRANCE