This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

CADD-Solis Ambulatory Infusion Pumps (2015-06-01)

Starting date:
June 1, 2015
Posting date:
June 12, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-53765

Recalled Products

A. CADD-SOLIS VIP Ambulatory Infusion Pump

B. CADD-SOLIS Ambulatory Infusion Pumps

Reason

Smiths Medical reports the intermittent occurrence of binding of the locking assembly on some CADD-Solis pumps. Binding on the cassette/keypad lock can occur after latching the CADD-Solis medication cassette reservoir or administration set disposable to the pump. When binding occurs, it can prevent the key from fully rotating the cassette/keypad lock to the locked (engaged) position. To start an infusion with pump models 2111 and 2112, and model 2120, when in PCA mode, the lock must be fully engaged. This issue is limited to specific serial numbers only (1061043 through 1067598).

Affected products

A. CADD-SOLIS VIP Ambulatory Infusion Pump

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

21-2120-0102-02                       

21-2120-0102-51

Companies
Manufacturer

Smiths Medical ASD, Inc.

1265 Grey Fox Road

St. Paul

55112

Minnesota

UNITED STATES



B. CADD-SOLIS Ambulatory Infusion Pumps

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

21-2111-0200-02                       

21-2111-0300-02                       

21-2111-0300-50                            

21-2112-0300-50

Companies
Manufacturer

Smiths Medical ASD, Inc.

1265 Grey Fox Road

St. Paul

55112

Minnesota

UNITED STATES