Class 3 Device Recall Porex Nostril Retainers

• Date Initiated by Firm: July 11, 2006
• Date Posted: September 22, 2006
• Recall Status: Terminated on February 06, 2007
• Recall Number: Z-1515-06
• Recall Event ID: 36172
• Product Classification: Nostril retainers - Product Code LYA
• Product: Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA.
• Code Information: Catalog number 7241-Lot number B002E05N
• FEI Number: 1000131961
• Recalling Firm/ Manufacturer: Porex Surgical, Inc.; 15 Dart Rd; Newnan GA 30265-1017
• For Additional Information Contact: Jerri Davis; 770-515-7735
• Manufacturer Reason for Recall: Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material
• FDA Determined Cause: Other
• Action: Consignees were contacted by phone for product return and with a follow up in letter dated 07/12/2006.
• Quantity in Commerce: 27 units
• Distribution: Worldwide distribution ---- including states of AZ, CA, CT, DC, FL, NC, PA, WI and country of Germany. AZ, CA, CT, DC, FL, NC, PA, WI and Germany
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.