Device Recall Super ArrowFlex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port 의 리콜

Recall

58331

Class 2

Z-2048-2011

2011-03-25

Terminated

United States

2014-01-29

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99000

Labeling discrepancy - the outer corrugate label as well as a card inside the package state the product contains dry natural rubber - this is not duplicated on the unit packaging.

The firm, Arrow International, sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated March 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately quarantine any products with the listed lot numbers; complete and return the Immediate Attention Request form via fax to 800-343-2935 indicating how much product they have in stock and whether they need labels. In the event that an alternative approach is needed, the customers are to contact Arrow Customer Service for more information. Once the labels have been received and applied the product can be released from quarantine. An Arrow's Sales Representative will pay a personal visit to their customers and obtain the quantity and the amount of labels they need. If you have any other questions, feel free to contact your local sales representative or Customer Service at 866-396-2111.