Type of Product |
Medical Device |
TGA Recall Reference |
RC-2015-RN-00263-1 |
Product Name/Description |
AngioDynamics Morpheus Smart PICC CT (Central venous catheters)
Catalogue number:12102602 Lot number: 583841
Catalogue number: 12102605 Lot number: 588129
Catalogue number:12102802 Lot number: 601006
Catalogue number:12102813 Lot number: 603510
ARTG number: 204787 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
23/03/2015 |
Responsible Entity |
|
Reason/Issue |
AngioDynamics, the manufacturer of Morpheus Smart PICC CT Kits is conducting a medical device recall on specific kit / lot numbers of power injectable PICC catheters. Based on a review of complaints, AngioDynamics has determined that the power injectable PICC catheters contained in these kits exhibit a higher than anticipated rate of extension tube fracture or leakage. Use of the PICC catheters that are subject to this recall may have an increased incidence of extension tube fractures or leakage which would require replacement of the PICC catheter. |
Recall Action |
Recall |
Recall Action Instructions |
Customers are advised to segregate affected stock to a secure location for return to the Medical Specialties Australia. This action has been closed-out on 1/06/2016. |
Contact Information |
02 9417 7955 - Medical Specialties Australia |