FDA Device recall Z-1341-2017
Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor…
- FDA Device
- Class II
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class II recall of Minor Pack, part number AMS3782(B Minor Pack, part number AMS3782(C Minor Pack, part number CMP1560 Minor Pack, part number PSS3518(B Minor… by Windstone Medical Packaging, citing 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 sterili….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1341-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-11 |
| Published | 2017-03-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Windstone Medical Packaging |
| Distribution | 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, WA |
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
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.
Identifiers
| code_info | Lot number and expiration date 100188, 10/19/2019 100884, 9/17/2019 84683, 5/27/2018 85122, 6/3/2018 85476, 8/17…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1341-2017%22
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