Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8515, Size 7 1/2, 4 boxes of 50, Sterile, Distribute
FDA device recall Z-1586-2009 · posted 2009-07-24 · Terminated
Recall details
- Recalling firm
- Ansell Healthcare Products LLC
- Reason for recall
- Premature degradation which could result in tearing during use.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KGO
- Quantity affected
- 560,000 total units--all lots.
- Distribution
- Nationwide Distribution and Canada.
- Date initiated
- 2009-05-01
- Date posted
- 2009-07-24
- Date terminated
- 2010-04-12
- Location
- Dothan, AL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) (K984558) | Ansell Perry | 1999-02-26 |