Recall Z-0893-2017 ยท KGO Surgeon'S Gloves
Ansell Healthcare Products LLC
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
| Date | Oct 24, 2016 |
| Status | Terminated |
| Reason | 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 | 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 v |
| Quantity | 15 Cartons |
| Distribution | US Distribution to the states of : PA, FL, NJ, IL and MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984558 | DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) Ansell Perry, Feb 26, 1999 |