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U.S. Department of Health and Human Services

Class 2 Device Recall PowderFree Latex Surgical Gloves

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  Class 2 Device Recall PowderFree Latex Surgical Gloves see related information
Date Initiated by Firm September 03, 2010
Date Posted December 15, 2010
Recall Status1 Terminated 3 on November 28, 2011
Recall Number Z-0621-2011
Recall Event ID 57269
510(K)Number K000295  
Product Classification Surgeon's gloves - Product Code KGO
Product ENCORE (R) Microptic (R) Powder-Free Latex Surgical Gloves, 1 Pair, Size 5¿, Sterile R, CE 0086, EC REP Ansell (UK) Ltd., Tamworth, Staffordshire, B79 7UL UK, Ansell Lanka (pvt) Ltd., Biyagama Export Processing Zone, Biyagama, Sri Lanka

Intended use: Surgical Gloves
Code Information Lot 1003006005
Recalling Firm/
Manufacturer		 Ansell Healthcare Products LLC
1635 Industrial Rd
Dothan AL 36303-5750
For Additional Information Contact Phillip Corke
732-345-5400
Manufacturer Reason
for Recall		 open package seams on sterile gloves
FDA Determined
Cause 2		 Other
Action The firm, Ansell, sent a letter dated September 3, 2010 to all customers. The letter described the product, problem and actions taken. An Ansell representatives will contact the customer to remove the gloves bearing the noted lot number from their facility; Ansell will ensure that the gloves removed will be replaced shortly with products from a different manufacturing batch and the recall was extended to the retail (hospital and clinic) level requesting that the product be returned. If you have any questions, contact US (334) 615-2563, international telephone 01.34.24.52.52 and email: infofrance@eu.ansell.com.
Quantity in Commerce 4000 units
Distribution International distribution only: France and Germany
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 = KGO and Original Applicant = ANSELL PERRY
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