FDA recall Z-0097-2024

Ansell Healthcare Products LLC · Class II · device

Product

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

Reason for recall

Some surgical glove sterile pouches were not completely sealed.

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.

Key facts

Status
Ongoing
Initiation date
2023-08-03
Report date
2023-10-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Reno, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0097-2024