PORTACATH and PORTACATH II implantable venous and arterial access systems 의 리콜

Recall

66234

Class 2

Z-2268-2013

2013-09-10

2013-09-23

Terminated

United States

2014-10-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121805

Smiths medical is conducting a voluntary recall of port-a-cath¿ and port-a-cath¿ ii implantable venous and arterial access systems and introducer sets. smiths medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these sets. smiths medical has received no reports.

Smiths Medical ASD, Inc. sent an Urgent Field Safety Notice dated September 6, 2013, to all affected customers. The letter described the problem and the product involved in the recall. The letter included the "Advice on Action to be Taken by the User" which instructed consignees to inspect and remove affected devices and to complete and return the "Urgent Field Safety Notice Confirmation Form. The letter also included information on the "Transmission of this Urgent Field safety Notice" which included information where customers should report issues related to the product to Smiths Medical's Global Complaint Department at 1-866-216-8806 or globalcomplaints@smiths-medical.com. For questions on the information provided they should contact 800-258-5361 (Smiths Medical's Customer Service Department). For questions regarding this recall call 1-800-332-0178.