Agency classClass IIOur severity:High FDA (Devices)·Z-1327-2015·Announced 2015-04-01

Ameda Dual Short Term HygieniKit Milk Collections System Recalled for Lack of Sterilization

Ameda is recalling its Dual Short Term HygieniKit Milk Collections System because the devices were not sterilized. Consumers should stop using the product and contact the manufacturer.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device intended for infant feeding that was not sterilized, posing a risk of harm without reported injuries.

Plain-English summary

Ameda, Inc. is recalling the Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115, Lot 5B01). The recall is being conducted because the devices were not sterilized. The product 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 for feeding to a baby.

The affected product consists of 12 collection systems in primary packaging with a Tyvek header, contained within a secondary corrugated shipper. The recall covers nationwide distribution, including California, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Missouri, Mississippi, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, and Washington.

Consumers who have purchased this product should stop using it immediately. They are advised to contact Ameda, Inc. for further instructions on how to proceed with the recall.

The recalled product

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…
Manufacturer: Ameda, Inc.
Category: Medical Device — Breast Pump Accessories
Hazard: infection-risk
lack-of-sterilization
Affected units: 12

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

SKU 17115
Lot 5B01

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Ameda, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Ameda, Inc.

See all →

Low
AMEDA Recalls Purely Yours Breast Pumps Due to Incorrect Power Adapter
FDA (Devices) · 2018-02-21
High
Ameda One-Hand Manual Breast Pump Recalled for Lack of Sterilization
FDA (Devices) · 2015-04-01

Same hazard · infection risk