FDA Enforcement
Class II
Terminated
Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room
Recall: Z-0154-2017
·
Reported October 26, 2016
Enforcement
- Recall Number
- Z-0154-2017
- Event ID
- 71968
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Windstone Medical Packaging, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 26, 2016
- Initiation Date
- April 22, 2015
- Classification Date
- October 20, 2016
- Termination Date
- October 25, 2016
- Address
- 1602 4th Ave N, N/A, Billings, MT, 59101-1521, United States
Description
Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room
Reason
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.
Code Info
Lot Numbers/Expiration Dates: 57223 2/26/2015 58307 4/10/2015 60261 7/17/2015 63765 11/15/2015 64007 7/5/2015 64597 1/6/2016 65800 11/5/2015 70762 10/25/2016 72336 12/9/2016 72759 1/24/2017 73439 1/27/2017 74083 4/25/2017 75079 6/25/2016 77743 9/17/2017 80762 8/2/2017
Distribution
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Quantity
288 kits