FDA Recall
Terminated
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).
Recall: Z-0773-2020
·
Initiated December 2, 2019
Recall
- Recall Number
- Z-0773-2020
- Event Number
- 84368
- Firm
- Medela Inc
- FEI Number
- 1419937
- Product Code
- OMP
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- December 2, 2019
- Terminated
- November 2, 2020
- Address
- 1101 Corporate Dr, McHenry, IL, 60050-7006
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).
Reason
Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
Action
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 [email protected] or call 888-835-5968.
Distribution
AL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA
Quantity
331