FDAClass IIOctober 18, 2023

GAMMEX NON-LATEX PI GREEN Surgical gloves recall

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

Why was GAMMEX NON-LATEX PI GREEN Surgical gloves recalled?

Some surgical glove sterile pouches were not completely sealed.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
Recalling firm
Ansell Healthcare Products LLC
Quantity
1511
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.
Recall date
October 18, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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