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Class 2 Device Recall ENCORE(R) UNDERGLOVE |
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Date Initiated by Firm |
June 10, 2011 |
Date Posted |
July 18, 2011 |
Recall Status1 |
Terminated 3 on January 10, 2013 |
Recall Number |
Z-2843-2011 |
Recall Event ID |
59155 |
510(K)Number |
K051793
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Product Classification |
Powder free latex surgeons gloves - Product Code NPD
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Product |
ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018470, Size 7, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka
Surgical gloves |
Code Information |
All codes distributed from February 2008 through May 2011 |
Recalling Firm/ Manufacturer |
Ansell Healthcare Products LLC 1635 Industrial Rd Dothan AL 36303-5750
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For Additional Information Contact |
Phillip Corke 732-345-5400
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Manufacturer Reason for Recall |
Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
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FDA Determined Cause 2 |
Other |
Action |
Ansell Healthcare Products LLC sent an Urgent Voluntary Recall letter dated June 9, 2011, to all affected customers on June 10 and 13, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconstinue use and distribution of any of the affected product and return them to the firm. If the customer distributed gloves further, customers were advised to forward a copy of the notification letter along with their tracking number to their customers.
Customers were instructed to complete and return the attached Response Form to Ansell by fax at 1-800-722-8155. Returned product would be replaced or credited to the customer. |
Quantity in Commerce |
289598 pairs |
Distribution |
Nationwide Distribution |
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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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510(K) Database |
510(K)s with Product Code = NPD and Original Applicant = ANSELL HEALTHCARE PRODUCTS, LLC
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