Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8514, Size 7, 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.
FDA Recall Z-1585-2009 · Posted 2009-07-24
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Recalling FirmAnsell Healthcare Products LLC
Recall StatusTerminated
Product CodeKGO
Date Initiated2009-05-01
Date Terminated2010-04-12
Product Quantity560,000 total units--all lots.
Reason for Recall
Premature degradation which could result in tearing during use.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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