Ameda Dual Short Term HygieniKit Milk Collections System — Class II medical device recall Z-1327-2015
Terminated recall by Ameda, Inc., reported 2015-04-01, distributed nationwide. Devices were not sterilized
| Recall number | Z-1327-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ameda, Inc., Buffalo Grove, IL, United States |
| Recall initiated | 2015-02-12 |
| Classified | 2015-03-26 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2017-07-21 |
| Distributed | Nationwide (US) |
| Quantity | 12 collection |
| Lot numbers | 5B01 |
Product
Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.
Reason for recall
Devices were not sterilized
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-1327-2015. 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.