Device product
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Z-0711-2024
Product summary
- Event
- Event 93560
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,100 gowns
- Official record key
device-enforcement:Z-0711-2024
Official wording
Reason: Surgical gowns were manufactured with the wrong sleeve.
Code information: Lot #11023060120, UDI (01)40080196029755(11)230615(10)11023060120.
Distribution pattern: Distribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.
Derived failure modes
-
Unknown
Surgical gowns were manufactured with the wrong sleeve.