Z-0711-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 17, 2024
- Initiation Date
- November 29, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,100 gowns
Product Description
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 Pattern
Distribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.
Code Information
Lot #11023060120, UDI (01)40080196029755(11)230615(10)11023060120.