Recall Z-1589-2009 ยท KGO Surgeon'S Gloves
Ansell Healthcare Products LLC
Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8518, Size 9, 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.
| Date | Jul 24, 2009 (initiated May 1, 2009) |
| Status | Terminated |
| Reason | Premature degradation which could result in tearing during use. |
| Root cause | 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 | 560,000 total units--all lots. |
| Distribution | Nationwide Distribution and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984558 | DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) Ansell Perry, Feb 26, 1999 |