FDA recall Z-0711-2024

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.

Reason for recall

Surgical gowns were manufactured with the wrong sleeve.

Distribution

Distribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.

Key facts

Status
Ongoing
Initiation date
2023-11-29
Report date
2024-01-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0711-2024