Z-0893-2017Class II

Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone...

Name: Z-0893-2017 Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone...
Creator: Ansell Healthcare Products LLC
Published: 2016-10-24
License: https://open.fda.gov/license/

Ansell Healthcare Products LLC / initiated 2016-10-24 / Terminated / root cause: packaging

FDA source

Ansell Healthcare Products LLC began a recall of Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V... on 2016-10-24. FDA classified it as Class II and gives the reason as "Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0893-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-24
Posted: 2016-12-22
Terminated: 2017-10-23
Recalling firm: Ansell Healthcare Products LLC
Product: Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC. 1635 Industrial Road Dothan, AL 36303, USA TEL USA- 1-800-952-9916 CAN- 1-844-494-7854 catalog #20277285
Product code: KGO Surgeon'S Gloves
Reason for recall: Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Ansell Healthcare Products, LLC. sent an Urgent: Voluntary Surgical Glove Recall letter dated October 28, 2016, to all affected customers. The letter identified the problem the product and the action the customer needs to take. Please check your product stock at the warehouse and shelf level in order to advise us directly if any gloves having the recalled lot numbers are found. This information, along with your tracking number, must be communicated to our Customer Service Department by calling 1-800-952-9916, or by returning the attached Response Form to Ansell by fax at 1-800-722-8155, or via email [email protected] . Returned product will either be replaced or credited without delay. Your Ansell representative will be available to follow up with you regarding any concerns you may have.
Quantity in commerce: 15 Cartons
Distribution: US Distribution to the states of : PA, FL, NJ, IL and MA.
Product codes and lots: Lot 1607018105

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0893-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0893-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22

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)