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

FDA device recall Z-0097-2024 · posted 2023-10-11 · Open, Classified

Recall details

Recalling firm

Ansell Healthcare Products LLC

Reason for recall

Some surgical glove sterile pouches were not completely sealed.

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.

Root cause

Process control

Status

Open, Classified

Product code

KGO

Quantity affected

378

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.

Date initiated

2023-08-03

Date posted

2023-10-11

Location

Reno, NV

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