CADD Medication Cassette Reservoir,50ml (2015-01-28)

Starting date:

January 28, 2015

Posting date:

February 16, 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-43735

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  Reason
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  Affected products

Recalled Products

A) CADD Medication Cassette Reservoir,50ml

Reason

Smiths Medical has received a small number of complaints of leakage in some CADD medication cassette reservoirs, 50ml. A small amount of leaking has been found to occur at the welding of the tube to the internal reservoir bag on some cassettes. If noticed during cassette filling, it could result in a delay of therapy while an alternative cassette is obtained. If noticed during fluid delivery with the patient, it could result in an interruption in therapy while the cassette is replaced. Smiths Medical has received no reports of serious injury or death related to this issue.

Affected products