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Recall Observatory FDA recall evidence

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

December 02, 2019

Class II

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

    reason.no_named_rule · v1.0.0

    Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.