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U.S. Department of Health and Human Services

Class 2 Device Recall Flexichamber AntiStatic Valved Collapsible Holding Chamber

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  Class 2 Device Recall Flexichamber AntiStatic Valved Collapsible Holding Chamber see related information
Date Initiated by Firm May 16, 2016
Date Posted June 15, 2016
Recall Status1 Terminated 3 on February 10, 2017
Recall Number Z-1995-2016
Recall Event ID 74197
510(K)Number K140062  
Product Classification Holding chambers, direct patient interface - Product Code NVP
Product Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
Code Information Lot 5295 (trade) NDC 13551-901-01; Lot 5313 (demonstration units) and 5325 NDC 13551-902-01
Recalling Firm/
Manufacturer		 FSC Laboratories, Inc
6000 Fairview Rd Ste 600
Charlotte NC 28210-2201
For Additional Information Contact Lauren Stival
636-449-5866
Manufacturer Reason
for Recall		 Product had torn/loose seal around the mouthpiece.
FDA Determined
Cause 2		 Process control
Action Letters were sent to consignees on 5/16/2016 informing them of the recall and requesting that they immediately discontinue use of the product. The letter included a reply form to be returned to FSC Laboratories.
Quantity in Commerce 1435 units
Distribution US Nationwide distribution.
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 = NVP and Original Applicant = FSC LABORATORIES, INC.
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