SVS LLC: Device Recall
Recall #Z-2320-2024 · 05/13/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2320-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- SVS LLC
- Status
- Ongoing
- Date Initiated
- 05/13/2024
- Location
- Charlotte, NC, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 155,540 inner boxes
Reason for Recall
Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner box indicating another size).
Product Description
Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.
Distribution Pattern
US Nationwide distribution in the states of MI, NE, FL, GA, PA, AR, CO, and NY.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.