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GAMMEX recallZ-0096-2024 · Ansell Healthcare Products LLC · initiated Aug 3, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ansell Healthcare Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Some surgical glove sterile pouches were not completely sealed.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0096-2024
Status
Open, Classified
Initiated by the company
Aug 3, 2023
Posted by the FDA
Oct 11, 2023
Recalling firm
Ansell Healthcare Products LLC
Quantity
1511
Product code
KGO
FDA submissions
K111139
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.

Product description

GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290

Code information (models, lots, serial numbers)

Lot: 2203434204, REF/UDI-DI: 20685255/00884792385206, 20685260/00884792385213, 20685265/00884792385220, 20685270/00884792385237, 20685275/00884792385244, 20685280 00884792385251, 20685285 00884792385268, 20685290 00884792385275.

Devices named in this recall

8 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 93045).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page