Gammex Non-Latex PI Green Surgical Gloves (Ansell) – pouch seal issue (2023)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Some surgical glove sterile pouches were not completely sealed.

Recommended Action

Per FDA guidance

On 8/3/23, recall notices were mailed or emailed to customers and distributors. Customers who did not respond were contacted via phone. Customers and distributors were asked to do the following: 1) Communicate with all personnel that utilize the product of the risk of and need to discontinue use of the impacted products. 2) Complete the customer Response Form at http://www.novasyte.com/ansell/capa-296-2023 and 3) Return impacted product. If impacted product was purchased from a distributor, contact your distributor directly for further instructions and replacement products. Customers with questions can call 1-800-952-9916 or email CustomerServiceUS@Ansell.com In addition, distributors were asked to take every effort to communicate the recall situation to their impacted End-User customers that received this product. We recommend that distributors attempt to contact and notify each customer at least three times by e-mail and/or by phone. See end-user customer letters. Please contact Novasyte with questions via email ansell-capa-296-2023@iqvia.com or at (855) 558-2741. visit http://www.novasyte.com/ansell/capa-296-2023 to complete the necessary acknowledgement form If you have questions on this notification, please reach out directly via CustomerServiceUS@Ansell.com or 1-800-952-9916.