Recall Z-0773-2020 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Medela Inc
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).
| Date | Dec 2, 2019 |
| Status | Terminated |
| Reason | Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging. |
| Root cause | 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 medelareturns@medela.com or call 888-835-5968. |
| Quantity | 331 |
| Distribution | AL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia Medela AG, Apr 6, 2017 |