Recall Z-1327-2015 ยท HGY Pump, Breast, Non-Powered
Ameda, Inc.
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 p
| Date | Mar 26, 2015 (initiated Feb 12, 2015) |
| Status | Terminated |
| Reason | Devices were not sterilized |
| Root cause | Under Investigation by firm |
| Action | Ameda sent an URGENT: MEDICAL DEVICE RECALL letter dated February 12, 2015 to all affected customers. The letter included instructions for distributors to: 1) quarantine the recalled products; 2) complete and return the enclosed Recall Response Forms within 3 days of receiving the letter; 3) upon receipt of the completed Recall Response Form, an Ameda representative would contact the distributor to make arrangements for the return of the recalled products; 4) Ameda will use the information provided in the returned Recall Response Form to contact the distributor's customers of record to arran |
| Quantity | 12 collection systems |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011519 | AMEDA HYGIENIKIT Hollister, Inc., Aug 15, 2001 |