Device product
Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS1842(A Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part numbre PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706 Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A Extremity Pack, part number PSS2706(A
Z-1295-2017
Product summary
- Event
- Event 76280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 810 kits
- Official record key
device-enforcement:Z-1295-2017
Official wording
Reason: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
Code information: Lot number and expiration date 100226, 9/11/2019 101400, 10/7/2019 84373, 5/28/2018 84678, 6/8/2018 84896, 5/26/2018 84959, 7/29/2018 85470, 2/23/2017 85505, 7/23/2018 85547, 8/23/2018 85695, 7/8/2018 85846, 8/5/2018 86258, 9/19/2018 86509, 9/28/2018 86663, 8/11/2019 86686, 9/9/2018 86908, 9/13/2018 87155, 9/16/2018 87730, 7/5/2017 87968, 9/6/2018 88008, 7/1/2017 88862, 2/7/2018 89394, 11/15/2017 89546, 7/21/2017 89832, 12/29/2018 95313, 9/16/2019 95453, 1/22/2019 95880, 6/12/2019 96000, 1/6/2019 96383, 5/25/2018 96384, 5/13/2018 96923, 5/1/2019 97709, 5/1/2019 99376, 6/7/2019
Distribution pattern: Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
Derived failure modes
-
Unknown
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.