FDA recall Z-0760-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

RUMMELL, Medline Item No. ST006ST

Reason for recall

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2024-11-12
Report date: 2025-01-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0760-2025