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
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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
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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 |
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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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