Rappel de produits de santé

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

  1. EVODIAL 1.3
  2. EVODIAL 1.6
  3. EVODIAL 2.2
  4. 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