Arrow Transradial Artery Access products 의 리콜

Recall

66586

Class 2

Z-0468-2014

2013-10-09

2013-12-09

Terminated

United States

2015-08-12

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122655

There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.

Arrow International sent an Urgent Medical Device Recall Notification letter dated October 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product,to return product complete the enclosed Recall Acknowledgement Form and fax to 1-800-343-2935, ATTN: Customer Service. Customers were asked to completed the Recall Acknowledgement Form even if they have none of the affected product. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-800-343-2935. For questions regarding this recall call 610-378-0131.