Exact FDA event identifier

Event 70599

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: February 12, 2015
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Ameda, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-1326-2015

Recall number: Z-1326-2015
Initiated: February 12, 2015
Classification: Class II
Status: Terminated
Recalling firm: Ameda, Inc.
Quantity: 1763

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Devices were not sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices were not sterilized

Code information

SKU 17161; Lot 5A22

Distribution pattern

Nationwide Distribution including CA, FL, GA, IA, IL, IN, LA, MA, MD, MO, MS, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WA.

device · product 2 of 2

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.

Z-1327-2015

Recall number: Z-1327-2015
Initiated: February 12, 2015
Classification: Class II
Status: Terminated
Recalling firm: Ameda, Inc.
Quantity: 12 collection systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Devices were not sterilized

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices were not sterilized

Code information

SKU 17115; Lot 5B01

Distribution pattern

Nationwide Distribution including CA, FL, GA, IA, IL, IN, LA, MA, MD, MO, MS, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WA.