Z-1327-2015 Class II Terminated
FDA device recall Z-1327-2015 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: 12 collection systems.
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
- 12 collection systems
Product Description
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.
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 17115; Lot 5B01