Recall Z-0893-2017
Ansell Healthcare Products LLC · initiated October 24, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot 1607018105
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.
FDA-determined cause: Packaging change control
Action taken
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 customerserviceus@ansell.com . 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.
Details
- Recall number
- Z-0893-2017
- Initiated
- October 24, 2016
- Terminated
- October 23, 2017
- Product code
- KGO – Surgeon'S Gloves
- Quantity
- 15 Cartons
- Distribution
- US Distribution to the states of : PA, FL, NJ, IL and MA.
- Recalling firm
- Ansell Healthcare Products LLC, Iselin, NJ