| Class 2 Device Recall DERMA PRENE POWDERFREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) | |
Date Initiated by Firm | May 01, 2009 |
Date Posted | July 24, 2009 |
Recall Status1 |
Terminated 3 on April 12, 2010 |
Recall Number | Z-1586-2009 |
Recall Event ID |
52038 |
510(K)Number | K984558 |
Product Classification |
Surgeon's gloves - Product Code KGO
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Product | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8515, Size 7 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: 0810003405, 0810014405, 0810007905 and 0810015805. |
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 |
Manufacturer Reason for Recall | Premature degradation which could result in tearing during use. |
FDA Determined Cause 2 | Process control |
Action | The 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 Commerce | 560,000 total units--all lots. |
Distribution | Nationwide Distribution and Canada. |
Total Product Life Cycle | TPLC Device Report |
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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 = KGO
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