Recall Z-0773-2020
Medela Inc · initiated December 2, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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).
Codes / lots: 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.
Reason for recall
Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
FDA-determined cause: Packaging
Action taken
An Important Device Recall letter was sent to customers via certified mail beginning 12/02/2019. The letter identified affected product, stated the reason for recall, and customers can return or destroy affected product. A response form was asked to be returned. Questions can be addressed by email to medelareturns@medela.com or call 888-835-5968.
Details
- Recall number
- Z-0773-2020
- Initiated
- December 2, 2019
- Terminated
- November 2, 2020
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Quantity
- 331
- Distribution
- AL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA
- Recalling firm
- Medela Inc, McHenry, IL