Health product recall

20ml TransFix (2019-11-11)

Starting date:
November 11, 2019
Posting date:
November 29, 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-71726

Last updated: 2019-12-02

Affected Products

20ml TransFix

Reason

Tube seal defect, resulting in tubes leaking TransFix. The sealing error was caused by the use of incorrect settings for the induction sealer equipment used. The induction sealer had been unplugged since the last use which caused the settings to default. The settings of the machine were not checked before use, and the default settings were used instead of the validated settings.

Affected products

20ml TransFix

Lot or serial number

29830.02
TFB-20-1

Model or catalog number

TFB-20-1

Companies
Manufacturer
Cytomark
Whiteleaf Business Centre, 11 Little Balmer
Buckingham
MK1F 1TF
UNITED KINGDOM