FDA-Device2016-10-26Class II
Basic Kit, Part numbers BP1110(C and CMP1109(A. 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
53 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Basic Kit, Part numbers BP1110(C and CMP1109(A. convenience custom kits used for general surgery in hospital operating room
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0146-2017Don't want to check this manually?
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