Class II

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

MEDLINE INDUSTRIES, LP - Northfield · November 29, 2023

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.

States Affected

MD, OH, TN, TX, WI

Quantity Affected

2,100 gowns

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0711-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.