Device Recall Arrow Nerve Block Component, Product Code: AB18040N 의 리콜

Recall

69740

Class 2

Z-0573-2015

2014-11-10

2014-12-12

Terminated

United States

2016-09-08

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131448

Arrow is recalling certain lots of the continuous nerve block component, product code: ab-18040-n, due to a labeling inconsistency. the product lidstock incorrectly identifies the needle in the finished good as 17ga rather than the correct 18ga. the product included in the package is the correct 18ga size. no injuries or illnesses have been reported.

An urgent medical device recall notification, dated November 11, 2014, was sent to consignees which identified the product, problem, and action to be taken. Customers with affected stock were asked to immediately discontinue use and quarantine any products with the catalog and lot number. To return product, the Recall Acknowledgement Form should be completed and faxed to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will be in contact to provide instructions for the return of product. All customers were asked to complete the Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com.