FDA recall Z-2320-2024

SVS LLC · Class II · device

Product

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.

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).

Distribution

US Nationwide distribution in the states of MI, NE, FL, GA, PA, AR, CO, and NY.

Key facts

Status
Ongoing
Initiation date
2024-05-13
Report date
2024-07-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Charlotte, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2320-2024