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

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  Reason
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  Affected products

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