Recall Z-1587-2009
Ansell Healthcare Products LLC · initiated May 1, 2009
Product
Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8516, Size 8, 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.
Codes / lots: Lot Numbers: 0811015605, 0810008005, 0810014505, 0810015605 and 0811017805.
Reason for recall
Premature degradation which could result in tearing during use.
FDA-determined 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.
Details
- Recall number
- Z-1587-2009
- Initiated
- May 1, 2009
- Posted by FDA
- July 24, 2009
- Terminated
- April 12, 2010
- Product code
- KGO – Surgeon'S Gloves
- Quantity
- 560,000 total units--all lots.
- Distribution
- Nationwide Distribution and Canada.
- Recalling firm
- Ansell Healthcare Products LLC, Dothan, AL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1583-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8512, Size 6, 4…Premature degradation which could result in tearing during use. | 05/01/2009Terminated |
| Z-1584-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8513, Size 6 1/2, 4…Premature degradation which could result in tearing during use. | 05/01/2009Terminated |
| Z-1585-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8514, Size 7, 4…Premature degradation which could result in tearing during use. | 05/01/2009Terminated |
| Z-1586-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8515, Size 7 1/2, 4…Premature degradation which could result in tearing during use. | 05/01/2009Terminated |
| Z-1588-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8517, Size 8 1/2, 4…Premature degradation which could result in tearing during use. | 05/01/2009Terminated |
| Z-1589-2009 | Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8518, Size 9, 4…Premature degradation which could result in tearing during use. | 05/01/2009Terminated |