Health product recall

Medfusion 3500 and 4000 Syringe (2020-08-20)

Starting date:
August 20, 2020
Posting date:
September 1, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73839

Last updated:
2020-09-01

Affected Products

Medfusion 3500 and 4000 Syringe

Reason

Smiths Medical became aware of an unanticipated behavior in certain Medfusion 3500 and 4000 Syringe Pumps. If a bolus or loading dose is interrupted and a specific sequence of events occurs, inappropriate delivery (over or under-delivery of a bolus or loading dose) may occur. This issue has only been seen at two facilities in the United States.

Affected products

Medfusion 3500 and 4000 Syringe

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 4000-0105-51
  • 4000-0106-01
  • 67-2450-010600-01
  • 67-2450-010601-01
Companies
Manufacturer

Smiths Medical ASD, Inc.

6000 Nathan Lane North

Minneapolis

55442

Minnesota

UNITED STATES