Device product
Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor Pack, part number PSS3541(A
Z-1341-2017
Product summary
- Event
- Event 76280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 665 kits
- Official record key
device-enforcement:Z-1341-2017
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 100188, 10/19/2019 100884, 9/17/2019 84683, 5/27/2018 85122, 6/3/2018 85476, 8/17/2018 85717, 7/21/2018 86693, 9/3/2018 8695212/2/2018 87882, 11/11/2018 88612, 12/28/2018 88934, 11/28/2017 89105, 10/2/2018 89214, 11/19/2018 89473, 1/2/2019 89751, 1/21/2019 95234, 1/7/2019 96087, 1/9/2019 97240, 4/5/2018 97339, 5/13/2019 97525, 6/19/2019 97802, 6/10/2018 97958, 6/4/2019 98056, 6/29/2019 98591, 6/30/2019 99911, 9/24/2019 99918, 6/20/2019
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.