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U.S. Department of Health and Human Services

Class 3 Device Recall RELIEVA FLEX Sinus Guide Catheter

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  Class 3 Device Recall RELIEVA FLEX Sinus Guide Catheter see related information
Date Initiated by Firm April 28, 2015
Date Posted June 09, 2015
Recall Status1 Terminated 3 on June 10, 2015
Recall Number Z-1740-2015
Recall Event ID 71232
Product Classification Cannula, sinus - Product Code KAM
Product RELIEVA FLEX Sinus Guide Catheter F-70.
Catalog number GC070RF.

Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures.
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Code Information Catalog number GC070RF, Lot 120709i-cm, Expiry 7/31/2014.
Recalling Firm/
Manufacturer		 Acclarent, Inc.
1525B Obrien Dr
Menlo Park CA 94025-1463
For Additional Information Contact Gabriel Alfageme
650-687-5398
Manufacturer Reason
for Recall		 Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Acclarent sent an Urgent Medical Device Recall letter dated May 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed that if the affected catheter is still in inventory, it should be isolated and returned to Acclarent per instructions. Questions should be addressed to Gabriel Alfageme, Field Action Coordinator at 1-650-687-5398.
Quantity in Commerce 986
Distribution US in the state of Texas
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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