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U.S. Department of Health and Human Services

Class 3 Device Recall PolypVac

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  Class 3 Device Recall PolypVac see related information
Date Initiated by Firm April 07, 2014
Date Posted April 30, 2014
Recall Status1 Terminated 3 on May 14, 2014
Recall Number Z-1527-2014
Recall Event ID 67950
510(K)Number K133133  
Product Classification Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
Product PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.
Code Information Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014. 
Recalling Firm/
Manufacturer		 Laurimed LLC
500 Arguello St
Redwood City CA 94063-1566
For Additional Information Contact Brian DrBois
650-587-5296
Manufacturer Reason
for Recall		 The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
FDA Determined
Cause 2		 Component design/selection
Action All direct accounts were notified on April 8, 2014 with an Urgent: Medical Device Recall of PolypVac Microdebrider letter, sent by first class mail. The letter identified the affected product, the reason for the recall, and stated that the firm is in the process of implementing corrections. The firm is requesting that all unused lots be returned to them. Replacement devices will sent to customers. In addition, customers are to complete the attached Lot Information sheet. Questions should be directed to bdubois@laurimed.com or 650-587-5296.
Quantity in Commerce 58
Distribution Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.
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.
510(K) Database 510(K)s with Product Code = ERL and Original Applicant = LAURIMED LLC
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