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U.S. Department of Health and Human Services

Class 3 Device Recall Porex Nostril Retainers

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  Class 3 Device Recall Porex Nostril Retainers see related information
Date Initiated by Firm July 11, 2006
Date Posted September 22, 2006
Recall Status1 Terminated 3 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
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 2
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.
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