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