GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
This recall is currently active, issued October 11, 2023. It was issued by Ansell Healthcare Products Llc.
- Company
- Ansell Healthcare Products Llc
- Recall Initiated
- August 3, 2023
- Posted
- October 11, 2023
- Recall Number
- Z-0096-2024
- Quantity
- 1511
- Firm Location
- Reno, NV
- Official Source
- View on FDA website ↗
Reason for Recall
Some surgical glove sterile pouches were not completely sealed.
Distribution
Worldwide - US Nationwide distribution in the states of IN, OH, NY, VA, IL, TN, GA, NY, SC, WI, FL and the country of CA.
Lot / Code Info
Lot: 2203434204, REF/UDI-DI: 20685255/00884792385206, 20685260/00884792385213, 20685265/00884792385220, 20685270/00884792385237, 20685275/00884792385244, 20685280 00884792385251, 20685285 00884792385268, 20685290 00884792385275.
Root Cause
Process control
Action Taken
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.