Data Foundry

Medical device recalls 2017

Minor Pack — Class II medical device recall Z-1341-2017

Terminated recall by Windstone Medical Packaging, Inc., reported 2017-03-08, distributed in AZ, CA, CO, CT, FL, GA, IL, IN…. The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were rec

Recall numberZ-1341-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmWindstone Medical Packaging, Inc., Billings, MT, United States
Recall initiated2017-01-11
Classified2017-02-28
Reported by FDA2017-03-08
Terminated2017-05-03
DistributedAZ, 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
Quantity665 kits
Reason classessterility
Lot numbers100188, 100884, 84683, 85122, 85476, 85717, 86693, 8695212, 87882, 88612, 88934, 89105, 89214, 89473, 89751, 95234, 96087, 97240, 97339, 97525, 97802, 97958, 98056, 98591, 99911, 99918
Model numbersAMS3782, CMP1560, PSS3518, PSS3541

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 for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1341-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.