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Z-1326-2015 Class II Terminated

Recalled by Ameda, Inc. — Buffalo Grove, IL

FDA device recall Z-1326-2015 was initiated by Ameda, Inc. on February 12, 2015 and is designated Class II. Reason for recall: Devices were not sterilized The recall status is terminated (terminated July 21, 2017). Affected quantity: 1763.

Recall Details

Product Type: Devices
Report Date: April 1, 2015
Initiation Date: February 12, 2015
Termination Date: July 21, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1763

Product Description

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.

Reason for Recall

Devices were not sterilized

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.

Code Information

SKU 17161; Lot 5A22