Arrow Percutaneous Sheath Introducer Kits 의 리콜

Recall

68073

Class 2

Z-1713-2014

2014-04-14

2014-06-04

Terminated

United States

2016-10-14

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126904

Arrow is recalling the arrow¿ percutaneous sheath introducer kits due to dilator tip damage noted during internal inspection. dilator tip damage has the potential to result in vessel damage.

Teleflex/Arrow International sent an Urgent Medical Device Recall Notification letter dated April 17, 2014, to distributors and end users. 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 and to complete the enclosed Recall Acknowledgement Form and fax it to 1-800-343-2935 to return product. Customers would be contacted by a customer service representative for a Return Goods Authorization (RGA) Numbers and would be provided instructions for the return of the product. Customers should complete the form whether they have affected product or not. Customers with questions were instructed to call 1-800-343-2935. For questions regarding this recall call 610-378-0131.