FDA Recall Open, Classified

NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290

Recall: Z-0097-2024 · Initiated August 3, 2023

Recall

Recall Number
Z-0097-2024
Event Number
93045
Firm
Ansell Healthcare Products LLC
FEI Number
3011209798
Product Code
KGO
Status
Open, Classified
Root Cause
Process control
Initiated
August 3, 2023
Posted
October 11, 2023
Address
2301 Robb Dr, Reno, NV, 89523-1901

Description

NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290

Reason

Some surgical glove sterile pouches were not completely sealed.

Action

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 [email protected] 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 [email protected] 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 [email protected] or 1-800-952-9916.

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.

Quantity

378