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.
|