Breast Pack — Class II medical device recall Z-1277-2017
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 number | Z-1277-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Windstone Medical Packaging, Inc., Billings, MT, United States |
| Recall initiated | 2017-01-11 |
| Classified | 2017-02-28 |
| Reported by FDA | 2017-03-08 |
| Terminated | 2017-05-03 |
| Distributed | 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 |
| Quantity | 369 kits |
| Reason classes | sterility |
| Lot numbers | 100106, 100129, 100132, 100505, 100805, 85140, 86315, 87053, 87623, 87945, 88185, 88827, 89726, 94942, 96754, 97548, 98079, 98319, 99056, 99157, 99711 |
| Model numbers | AMS3238, AMS4419, AMS5750, AMS6120, PSS1784, PSS2272 |
Product
Breast Pack, part number AMS3238(A Breast Pack, part number AMS4419(A Breast Pack, part number AMS4419(B Breast Pack, part number AMS5750 Breast Pack, part number AMS5750(A Breast Pack, part number AMS6120 Breast Pack, part number PSS1784(B Breast Pack, part number PSS2272(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-1277-2017. 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.