Device product
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
Product summary
- Firm
- Ameda, Inc.
- Event
- Event 70599
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1763
- Official record key
device-enforcement:Z-1326-2015
Official wording
Reason: 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.
Derived failure modes
-
Unknown
Devices were not sterilized