Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1327-2015 — 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 fo

U.S. FDA — Device Enforcement · United States · 2015-02-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1327-2015
Date of alert: 2015-02-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ameda, Inc.
Product category: device
Product type: Devices

Reported risk: Devices were not sterilized

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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