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U.S. Department of Health and Human Services

Class 2 Device Recall Acclarent

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  Class 2 Device Recall Acclarent see related information
Date Initiated by Firm January 20, 2006
Date Posted February 24, 2006
Recall Status1 Terminated 3 on May 11, 2006
Recall Number Z-0559-06
Recall Event ID 34524
Product Classification Instrument, Ent Manual Surgical - Product Code LRC
Product Acclarent brand Relieva Sinus Inflation Device Kit;
Model BID30; The kit contains 1 inflation device, 1-10'' extension tube, 1-20cc syringe, 3-way stop-cock; Manufactured for Acclarent, Inc., 1525-B O''Brien Dr., Menlo Park, CA 94025
Code Information Catalog #, Lot #, Manufacture Date, Expiration Date: BID30, 99456168, 09/2005, 09/2010, BID30,99455806, 08/2005, 08/2010, BID30, 99455018, 08/2005, 08/2010, BID30, 99458283, 09/2005, 09/2010, BID30, 99457941, 10/2005, 10/2010, BID30, 99464320, 12/2005, 10/2008, BID30,,99464317, 11/2005, 11/2010  
Recalling Firm/
Manufacturer
Acclarent Inc
1525-B O'Brien Drive
Menlo Park CA 94025
For Additional Information Contact Su-Mien Chong
650-687-5888
Manufacturer Reason
for Recall
Device sterility may be compromised as evidenced by a loss of package integrity.
FDA Determined
Cause 2
Other
Action On 1/20/06 the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.
Quantity in Commerce 149 units
Distribution The product was released for distribution to 15 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the direct accounts (users) who received the recalled product. There is one Veterans Affairs account: Dept. of Veterans Affairs Medical Center PA, 1 215 823-4659, University & Woodland Avenues, Philadelphia, PA 19104, USA
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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