Device Recall Microline Surgical ReNew Laproscopic Long Fenestrated Grasper Forceps Tip 의 리콜

Recall

59469

Class 2

Z-3085-2011

2011-07-18

2011-08-29

Terminated

United States

2011-09-09

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102846

Mislabeled: renew product number 3262 (long fenestrated grasper) was packaged and labeled as product number 3642 (super-atrau fenestrated grasper). renew product number 3642 (super-atraumatic fenestrated grasper) was packaged and labeled as 3262 (long fenestrated grasper.

Microline Surgical sent a RECALL NOTICE letter dated July 18, 2011, 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 examine their inventory and quarantine product subject to the recall. If customers further distributed the product, customers should identify their accounts and notify them immediately of the product recall. Customers were instructed to contact Microline Customer Service to obtain a Return Authorization Number for return of the recalled item. Customers were asked to complete and return the enclosed Recall Return Response Form as soon as possible. For any questions customers were instructed to call the Regulatory Affairs Manager at 978-867-1726.