Ansell, 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.
Recall
- Recall Number
- Z-1584-2009
- Event Number
- 52038
- Firm
- Ansell Healthcare Products LLC
- FEI Number
- 1019632
- Product Code
- KGO
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- May 1, 2009
- Posted
- July 24, 2009
- Terminated
- April 12, 2010
- Address
- 1635 Industrial Rd, Dothan, AL, 36303-5750
Description
Ansell, 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.
Premature degradation which could result in tearing during use.
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.
Nationwide Distribution and Canada.
560,000 total units--all lots.