Z-2841-2011

ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018460, Size 6, Sterile, Manufactured...

Name: Z-2841-2011 ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018460, Size 6, Sterile, Manufactured...
Creator: Ansell Healthcare Products LLC
Published: 2011-06-10
License: https://open.fda.gov/license/

Ansell Healthcare Products LLC / initiated 2011-06-10 / Terminated

FDA source

Ansell Healthcare Products LLC began a recall of ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018460, Size 6, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road... on 2011-06-10. The reason FDA records is "Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2841-2011
Status: Terminated
Initiated: 2011-06-10
Posted: 2011-07-18
Terminated: 2013-01-10
Recalling firm: Ansell Healthcare Products LLC
Product: ENCORE(R) UNDERGLOVE, Latex, Powder-Free, Smooth Surgical Gloves, REF 2018460, Size 6, Sterile, Manufactured for Ansell Healthcare, 1635 Industrial Road, Dothan, AL 36303, Made in Sri Lanka Surgical gloves
Product code: NPD
Reason for recall: Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
FDA root cause: Other
Action: Ansell Healthcare Products LLC sent an Urgent Voluntary Recall letter dated June 9, 2011, to all affected customers on June 10 and 13, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconstinue use and distribution of any of the affected product and return them to the firm. If the customer distributed gloves further, customers were advised to forward a copy of the notification letter along with their tracking number to their customers. Customers were instructed to complete and return the attached Response Form to Ansell by fax at 1-800-722-8155. Returned product would be replaced or credited to the customer.
Quantity in commerce: 45692 pairs
Distribution: Nationwide Distribution
Product codes and lots: All codes distributed from February 2008 through May 2011

Product code NPD

K051793Class IEncore Sterile Powder-Free Latex Surgical Glove with Proprietary Coating (Containing Glycerine)Ansell Healthcare Products, LLC / cleared 2005-08-17

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)