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.
This recall has been terminated (originally issued July 24, 2009).
- Company
- Ansell Healthcare Products Llc
- Recall Initiated
- May 1, 2009
- Posted
- July 24, 2009
- Terminated
- April 12, 2010
- Recall Number
- Z-1586-2009
- Quantity
- 560,000 total units--all lots.
- Firm Location
- Dothan, AL
- Official Source
- View on FDA website ↗
Reason for Recall
Premature degradation which could result in tearing during use.
Distribution
Nationwide Distribution and Canada.
Lot / Code Info
Lot Numbers: 0810003405, 0810014405, 0810007905 and 0810015805.
Root Cause
Process control
Action Taken
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.
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