FDA-Device2016-10-26Class II
Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room
Windstone Medical Packaging, Inc.
Hazard
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Sold states
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Affected count
288 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0154-2017Don't want to check this manually?
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