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U.S. Department of Health and Human Services

Class 3 Device Recall Aplicare Advantage Dressing Change System

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  Class 3 Device Recall Aplicare Advantage Dressing Change System see related information
Date Initiated by Firm March 03, 2010
Date Posted April 08, 2010
Recall Status1 Terminated 3 on March 16, 2012
Recall Number Z-1310-2010
Recall Event ID 54823
Product Classification Central Line Dressing Change - Product Code NAD
Product Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile
Part number: A3402.

The product is used for Central Line Dressing Change.
Code Information Lot number: 35397.
Recalling Firm/
Manufacturer		 Aplicare, Inc.
550 Research Pkwy
Meriden CT 06450-7172
For Additional Information Contact Customer Service
203-630-4818
Manufacturer Reason
for Recall		 Incorrect expiration date on outer kit label-extended.
FDA Determined
Cause 2		 Error in labeling
Action Aplicare notified customers by telephone on March 3, 2010 followed with "Product Recall Notice" letter issued by e-mail to the distributor level. Product will be labeled with correct expiration date. Direct questions to your sales representative or customer service by calling 1-800-760-3236.
Quantity in Commerce 103 cases (20 each)
Distribution United States (CT, RI, NJ and OH).
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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