Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 po...
FDA Device Recall #Z-1327-2015 — Class II — February 12, 2015
Recall Summary
| Recall Number | Z-1327-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 12, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ameda, Inc. |
| Location | Buffalo Grove, IL |
| Product Type | Devices |
| 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.
Lot / Code Information
SKU 17115; Lot 5B01
Other Recalls from Ameda, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0616-2018 | Class III | Purely Yours Breast Pump. Model 17070PMW and M... | Jul 10, 2017 |
| Z-1326-2015 | Class II | Ameda One-Hand Manual Breast Pump (SKU 17161) -... | Feb 12, 2015 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.