Device product

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

Z-0096-2024

August 03, 2023

Class II

Product summary

Firm: Ansell Healthcare Products LLC
Event: Event 93045
Status: Ongoing
Classification: Class II
Quantity: 1511
Official record key: device-enforcement:Z-0096-2024

Official wording

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

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

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.