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

Recall Z-1326-2015 — Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction.

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-1326-2015
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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Recall Z-1326-2015 — Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction.

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