FDA-Device2024-01-17Class II
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Surgical gowns were manufactured with the wrong sleeve.
Sold states
Distribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.
Affected count
2,100 gowns
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0711-2024Don't want to check this manually?
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