FDA Enforcement
Class II
Terminated
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
Recall: Z-0893-2017
·
Reported December 28, 2016
Enforcement
- Recall Number
- Z-0893-2017
- Event ID
- 75737
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ansell Healthcare Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 28, 2016
- Initiation Date
- October 24, 2016
- Classification Date
- December 22, 2016
- Termination Date
- October 23, 2017
- Address
- 111 Wood Ave S Ste 210, N/A, Iselin, NJ, 08830-2700, United States
Description
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
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.
Code Info
Lot 1607018105
Distribution
US Distribution to the states of : PA, FL, NJ, IL and MA.
Quantity
15 Cartons