Device Recall ARROW PICC powered by ARROW VPS Stylet 의 리콜

Recall

77589

Class 2

Z-0181-2018

2017-06-01

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156672

There is a possibility that the finished good kits may contain 5 fr peel-away sheaths instead of the required 4 fr peel-away sheaths.

Arrow International sent an Urgent Medical Device Recall Notification letter dated June 1, 2017, and Recall Acknowledgement Form to their domestic consignees via FedEx 2-day. Customers were advised to immediately inspect stock, discontinue use and quarantine any products with the product codes and lot numbers listed, so that the affected products can be returned to Arrow. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow the firm to document the amount of product you have on hand for return. A customer service representative will the customer with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow the company to document your receipt of the letter. Customers that have any questions can contact their local sales representative or Customer Service at 1-866-246-6990.