FDA recall Z-0633-2022

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

CURAD REUSABLE GEL HOT/COLD PACK

Reason for recall

The product contains natural rubber latex but the label states that it does not.

Distribution

US and Bahamas, Bermuda, Panama, Lebanon, Barbados, Honduras, Anguilla

Key facts

Status
Ongoing
Initiation date
2021-12-15
Report date
2022-02-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0633-2022