URGENT - FOR YOUR IMMEDIATE ATTENTION: SAFETY NOTIFICATION AND PRODUCT RECALL

August 3, 2023 – For the immediate attention of the following: Risk Management Director, Medical Device Safety Officers, O.R. Materials Manager

Ansell Healthcare Products LLC (“Ansell”) is conducting a voluntary Medical Device Product Recall of ONLY the following specific lot numbers of GAMMEX® NON-LATEX PI GREEN and NOVAPLUS™ GAMMEX® NON-LATEX PI GREEN Surgical Gloves:

• GAMMEX® NON-LATEX PI GREEN Surgical gloves: LOT Number 2203434204
• NOVAPLUS™ GAMMEX® NON-LATEX PI GREEN Surgical gloves: LOT Number 2203434604

Description of the problem

Ansell has identified that specific lot numbers of our GAMMEX® NON-LATEX PI GREEN and NOVAPLUS™ GAMMEX® NON-LATEX PI GREEN surgical gloves have the potential to exhibit an inadequate seal of the surgical glove sterile pouch. While these products followed our established quality assurance procedures throughout our production process, including sterilization, and were cleared for shipment to North America, it has been determined through a comprehensive investigation, triggered by four customer complaints, that some of the surgical glove sterile pouches were not completely sealed as required. As a result, Ansell is voluntarily recalling the specific lot numbers affected. There have been no adverse events reported or associated with this issue to date.

Please take the following immediate actions:

• INSPECT your inventory for affected product (see below for item codes and specific lot numbers). To further assist, a visual guide to help identify impacted product is included at the end of this notification. Retain a copy of this notice with the product.
• COMMUNICATE with all personnel that utilize the product of the risk of and need to discontinue use of the impacted products.
• COMPLETE Customer Response Form at http://www.novasyte.com/ansell/capa-296-2023 and return it to acknowledge receipt of this notification per regulatory requirements. Ansell is partnering with Novasyte, an independent partner that can assist. Please contact Novasyte via email at ansell-capa-296-2023@iqvia.com or at the phone line for this field action: (855) 558-2741.
• RETURN impacted product from the affected lots as soon as possible. Upon completion of the acknowledgement form, Ansell will partner with you to arrange for a return of the product, provide a credit, and offer the option to reship. If you purchased the affected product from a distributor, contact your distributor directly for further instructions and replacement products.
• MAINTAIN awareness of this notice until all affected product has been managed.

We continue to stress that the safety of clinicians and the patients they serve is our top priority, and thank you in advance for helping us to resolve this matter as quickly and effectively as possible. Please reach out directly with questions for Ansell at CustomerServiceUS@Ansell.com or 1-800-952-9916. Thank you for your continued trust and partnership.

REFERENCE - IMPACTED PRODUCT DETAILS

• GAMMEX® NON-LATEX PI GREEN Surgical gloves: LOT Number 2203434204
• NOVAPLUS™ GAMMEX® NON-LATEX PI GREEN Surgical gloves: LOT Number 2203434604

HOW TO IDENTIFY IMPACTED PRODUCT

To determine if your system is in possession of these specific impacted lots of GAMMEX® NON-LATEX PI GREEN or NOVAPLUS™ GAMMEX® NON-LATEX PI GREEN, please utilize the images below for reference.

To confirm, the impacted product would exhibit the following on both the pouches, dispenser boxes and cases:

• GAMMEX® NON-LATEX PI GREEN, LOT Number 2203434204
or
• NOVAPLUS™ GAMMEX® NON-LATEX PI GREEN, LOT Number 2203434604

Only products with the above-referenced combination of LOT Numbers are impacted by this voluntary recall. Please reference the images* below to see where the lot numbers can be found.

*Images are illustrative only for the purpose of identifying the lot number location on the package. All sizes of both referenced lots are being recalled.

ENDS