Health product recall

PRISMAFLEX ST100, ST150, TPE 2000, HF1000 and HF1400 Sets, OXIRIS Set (2019-04-25)

Starting date:
April 25, 2019
Posting date:
May 10, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69886

Last updated: 2019-05-10

Affected Products

  1. PRISMAFLEX ST100 and ST150 Set
  2. PRISMAFLEX TPE 2000 Set
  3. PRISMAFLEX HF1000 and HF1400 Sets
  4. OXIRIS Set

Reason

Baxter has received reports of kinked access lines observed during treatment using PRISMAFLEX sets. If the kink prevents blood flow, it causes the PRISMAFLEX control unit to alarm. The issue has been isolated to a subset of lots, based on production dates. A kinked access line has the potential to cause delay in therapy, blood circuit clotting as a result of reduced blood flow, or hemolysis. There have been no reports of serious injury associated with this issue and any are expected to be unlikely.

Affected products

A. PRISMAFLEX ST100 and ST150 Set

Lot or serial number

All lots expiring between 2020-03-01 and 2021-02-01.

Model or catalog number
  • PRISMAFLEX ST100 SET
  • PRISMAFLEX ST150 SET
Companies
Manufacturer
Gambro Industries
7 Avenue Lionel Terray, B.P. 126
Meyzieu
69883
FRANCE

B. PRISMAFLEX TPE 2000 Set

Lot or serial number

All lots expiring between 2020-03-01 and 2021-02-01.

Model or catalog number
  • PRISMAFLEX TPE 2000
Companies
Manufacturer
Gambro Industries
7 Avenue Lionel Terray, B.P. 126
Meyzieu
69883
FRANCE

C. PRISMAFLEX HF1000 and HF1400 Sets

Lot or serial number

All lots expiring between 2020-03-01 and 2022-02-01.

Model or catalog number
  • PRISMAFLEX HF1000
  • PRISMAFLEX HF1400
Companies
Manufacturer
Gambro Industries
7 Avenue Lionel Terray, B.P. 126
Meyzieu
69883
FRANCE

D. OXIRIS Set

Lot or serial number

All lots expiring between 2020-03-01 and 2021-03-01.

Model or catalog number
  • OXIRIS
Companies
Manufacturer
Gambro Industries
7 Avenue Lionel Terray, B.P. 126
Meyzieu
69883
FRANCE