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U.S. Department of Health and Human Services

Class 2 Device Recall ENCORE(R) UNDERGLOVE

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 Class 2 Device Recall ENCORE(R) UNDERGLOVEsee related information
Date Initiated by FirmJune 10, 2011
Date PostedJuly 18, 2011
Recall Status1 Terminated 3 on January 10, 2013
Recall NumberZ-2841-2011
Recall Event ID 59155
510(K)NumberK051793 
Product Classification Powder free latex surgeons gloves - Product Code NPD
ProductENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018460, Size 6, 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
FEI Number 1019632
Recalling Firm/
Manufacturer		 Ansell Healthcare Products LLC
1635 Industrial Rd
Dothan AL 36303-5750
For Additional Information ContactPhillip Corke
732-345-5400
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.
FDA Determined
Cause 2		Other
ActionAnsell 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 Commerce45692 pairs
DistributionNationwide Distribution
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) Database510(K)s with Product Code = NPD
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