Health product recall

T34 Ambulatory Syringe Pump (2018-11-26)

Starting date:
November 26, 2018
Posting date:
December 10, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device, Biologic/vaccine
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68528

Last updated: 2020-03-06

Affected products

T34 Ambulatory Syringe Pump

Reason

It has been identified that there can be a 2mm +/- overall length difference between various manufacturers' batteries that can be used in CME's T34TM Ambulatory Syringe Pumps. This could result in movement within the battery housing leading to a possible loss of connection, resulting in the pump powering down and a possible under infusion of pain medication occurring.

Affected products

T34 Ambulatory Syringe Pump

Lot or serial number

All lots.

Model or catalog number

T34

Companies
Manufacturer
Caesarea Medical Electronics Ltd.
16 Shacham Street, Industrial Park P. O. Box 4294
Caesarea
38900
ISRAEL