Device product

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

Z-0097-2024

August 03, 2023

Class II

Product summary

Firm: Ansell Healthcare Products LLC
Event: Event 93045
Status: Ongoing
Classification: Class II
Quantity: 378
Official record key: device-enforcement:Z-0097-2024

Official wording

Reason: Some surgical glove sterile pouches were not completely sealed.

Code information: Lot: 2203434604, REF/UDI-DI: V20685255/10014566400553, V20685260/10014566400607, V20685265/10014566400652, V20685270/10014566400706, V20685275/10014566400751, V20685280/10014566400805, V20685285/10014566400850, V20685290/10014566400904.

Distribution pattern: Worldwide - US Nationwide distribution in the states of IN, OH, NY, VA, IL, TN, GA, NY, SC, WI, FL and the country of CA.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Some surgical glove sterile pouches were not completely sealed.