Z-1587-2009

Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8516, Size 8, 4 boxes of 50, Sterile...

Name: Z-1587-2009 Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8516, Size 8, 4 boxes of 50, Sterile...
Creator: Ansell Healthcare Products LLC
Published: 2009-05-01
License: https://open.fda.gov/license/

Ansell Healthcare Products LLC / initiated 2009-05-01 / Terminated / root cause: manufacturing process

FDA source

Ansell Healthcare Products LLC began a recall of Ansell, Derma Prene Ultra, Powder-Free, Smooth Surgical Gloves, REF 8516, Size 8, 4 boxes of 50, Sterile, Distributed by Ansell Healthcare, 1635 Industrial... on 2009-05-01. The reason FDA records is "Premature degradation which could result in tearing during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1587-2009
Status: Terminated
Initiated: 2009-05-01
Posted: 2009-07-24
Terminated: 2010-04-12
Recalling firm: Ansell Healthcare Products LLC
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.
Product code: KGO Surgeon'S Gloves
Reason for recall: Premature degradation which could result in tearing during use.
Root cause tag: manufacturing process
FDA 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 in commerce: 560,000 total units--all lots.
Distribution: Nationwide Distribution and Canada.
Product codes and lots: Lot Numbers: 0811015605, 0810008005, 0810014505, 0810015605 and 0811017805.

Product code KGO

K984558Class IDerma Prene Powder-Free Synthetic Surgical Gloves (Chemotherapy Use)Ansell Perry / cleared 1999-02-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)