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U.S. Department of Health and Human Services

Class 2 Device Recall DERMA PRENE POWDERFREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)

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 Class 2 Device Recall DERMA PRENE POWDERFREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)see related information
Date Initiated by FirmMay 01, 2009
Date PostedJuly 24, 2009
Recall Status1 Terminated 3 on April 12, 2010
Recall NumberZ-1584-2009
Recall Event ID 52038
510(K)NumberK984558 
Product Classification Surgeon's gloves - Product Code KGO
ProductAnsell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8513, Size 6 1/2, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial Road, Dothan, AL, 36303, USA, Made in Sri Lanka. The device is made of synthetic rubber and is intended to be worn by operating room personnel to protect a surgical wound from contamination and for use in handling chemotherapy drugs.
Code Information Lot Numbers: 0810007705, 0812017905 and 0810015405.
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		Premature degradation which could result in tearing during use.
FDA Determined
Cause 2		Process control
ActionThe firm initiated the recall on May 1, 2009 by letter to Health Canada and by letter dated May 4, 2009 to its US and Canadian consignees. The letters described the affected product, issue and actions for customers. The recall was extended to the hospital and clinic level requesting that the product be returned. Direct questions to your Ansell Healthcare Products LLC representative.
Quantity in Commerce560,000 total units--all lots.
DistributionNationwide Distribution and Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KGO
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