FDA-Device2023-10-18Class II

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

Ansell Healthcare Products LLC
Hazard

Some surgical glove sterile pouches were not completely sealed.

Sold states
Worldwide - US Nationwide distribution in the states of IN, OH, NY, VA, IL, TN, GA, NY, SC, WI, FL and the country of CA.
Affected count
1511
Manufactured in
2301 Robb Dr, N/A, Reno, NV, United States
Products
GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0096-2024

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