FDA recall Z-1472-2022

MEDLINE INDUSTRIES, LP - SPT · Class II · device

Product

Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927

Reason for recall

Kits contain leaking bottles of isopropyl alcohol

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2022-06-06
Report date: 2022-08-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1472-2022