FDAFDA · Food and drugs·Recall number Z-0711-2024
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Published January 17, 2024 · Recall initiated: November 29, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Surgical gowns were manufactured with the wrong sleeve.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Distribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.
- Lot
- Lot #11023060120, UDI (01)40080196029755(11)230615(10)11023060120.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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