Z-0096-2024 Class II Ongoing
FDA device recall Z-0096-2024 was initiated by Ansell Healthcare Products LLC on August 3, 2023 and is designated Class II. Reason for recall: Some surgical glove sterile pouches were not completely sealed. The recall status is ongoing. Affected quantity: 1511.
Recall Details
- Product Type
- Devices
- Report Date
- October 18, 2023
- Initiation Date
- August 3, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1511
Product Description
GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
Reason for Recall
Some surgical glove sterile pouches were not completely sealed.
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.
Code Information
Lot: 2203434204, REF/UDI-DI: 20685255/00884792385206, 20685260/00884792385213, 20685265/00884792385220, 20685270/00884792385237, 20685275/00884792385244, 20685280 00884792385251, 20685285 00884792385268, 20685290 00884792385275.