Device 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).
Z-0773-2020
Product summary
- Firm
- Medela Inc
- Event
- Event 84368
- Status
- Terminated
- Classification
- Class II
- Quantity
- 331
- Official record key
device-enforcement:Z-0773-2020
Official wording
Reason: Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
Code information: 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 pattern: AL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA
Derived failure modes
-
Unknown
Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.