🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: February 12, 2015 Ameda Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    SKU 17115; Lot 5B01
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Ameda, Inc.
Reason for Recall:
Devices were not sterilized
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

SKU 17115; Lot 5B01

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1327-2015

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