| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00081-1 |
| Product Name/Description |
CADD Medication Cassette Reservoir, 50ml
Order Code: 21-7001-24
Batch Numbers: 14X297 and 14X323
Order Code: 21-7301-24
Batch Numbers: 14X324
ARTG Number: 145297 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
Smiths Medical has received a small number of complaints of leakage associated with the above-referenced Cassettes. 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 the leakage is noticed during Cassette filling, it could result in a delay of therapy while an alternative Cassette is obtained. If the leakage is noticed during fluid delivery with the patient, it could result in an interruption in therapy while the Cassette is replaced. |
| Recall Action |
Recall |
| Recall Action Instructions |
End users are requested to inspect their inventory and quarantine the affected Cassettes. A customer service representative will arrange for exchange of any unused affected Cassettes for credit or replacement. This action has been closed-out on 17/08/2016. |
| Contact Information |
02 9634 9200 - Smith's Medical Customer Service |