Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01369-1
Product Name/Description	Veletri Consumables Kit with non Flow-Stop CADD Medication Cassette Reservoirs Batch Numbers: 0308836, 0309014, 0309014-2, 0309757, 0309991, 0000310729, 0000310798, 0000311083, 0000311167, 0000311170 and 0000311674 ARTG Number: 219458 (Actelion Pharmaceuticals Australia Pty Ltd - Infusion administration set, infusion pump)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	30/10/2017
Responsible Entity	Actelion Pharmaceuticals Australia Pty Ltd
Reason/Issue	Actelion Pharmaceuticals Australia (Actelion) has been advised that certain non Flow-Stop CADD Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate. Specific Veletri Consumables Kits contain affected non Flow-Stop CADD Medication Cassette Reservoirs. Until replacement kits can be provided, it is recommended that the alternative Flow-Stop CADD Medication Cassette Reservoirs are used.
Recall Action	Recall
Recall Action Instructions	Actelion is advising users to inspect stock and quarantine affected stock. Affected stock can be returned to CH2 for replacement with unaffected stock. This action has been closed out on 18/02/2019
Contact Information	1300 116 441 - Actelion Pharmaceuticals Australia