Device 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
Z-0893-2017
Product summary
- Event
- Event 75737
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 Cartons
- Official record key
device-enforcement:Z-0893-2017
Official wording
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 information: Lot 1607018105
Distribution pattern: US Distribution to the states of : PA, FL, NJ, IL and MA.
Derived failure modes
-
Unknown
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.