🔍 RecallPedia

Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or more pieces depending on the kit size).

Class I - Dangerous
🏥 Medical Devices Recalled: December 2, 2019 Medela Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lots: 17110012731 / Exp 17-Nov-19, 17110022736 / Exp 22-Nov-19, 17120012746 / Exp 8-Dec-19, 18010012767 / 4-Jan-20, 18070012913 / 31-Jul-20, 18090012960 / Exp 28-Sep-20, 18110013046 / 5-Nov-20.
  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:
Medela Inc
Reason for Recall:
Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or more pieces depending on the kit size).

Product Codes/Lot Numbers:

Lots: 17110012731 / Exp 17-Nov-19, 17110022736 / Exp 22-Nov-19, 17120012746 / Exp 8-Dec-19, 18010012767 / 4-Jan-20, 18070012913 / 31-Jul-20, 18090012960 / Exp 28-Sep-20, 18110013046 / 5-Nov-20.

Distribution:

Distributed in: AL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0773-2020

Related Recalls

Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. 15 Days Negative Pressure Wound Therapy (Model 087.4012); c. 60 Days Negative Pressure Wound Therapy (Model 087.4014); d. Endure Negative Pressure Wound Therapy (Model 087.4020 ); e. 15 Days Negative Pressure Wound Therapy (Model 087.4022); f. 60 Days Negative Pressure Wound Therapy (Model 087.4024). Product Usage: The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

Medela

Class I - Dangerous

Device may display a battery missing error.

Feb 7, 2018 Infusion Pumps Nationwide View Details →