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TLC-II Portable VAD Driver (August 25, 2006)

Starting date:
August 25, 2006
Posting date:
October 30, 2006
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-32341

Reason

Valve disk material (lot number 20052904) utilized inside compressor (housed inside driver) has tendency to stick creating compressor noise and fluctuations in driver flow.

Affected products

TLC-II Portable VAD Driver

Lot or serial number

Serial #'s up to # 631R

Model or catalog number

20010-0000-081, 20010-2805-000

Companies

Manufacturer
Not Applicable