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).
FDA Recall Z-0773-2020 · Posted None
Recalling FirmMedela Inc
Recall StatusTerminated
Product CodeOMP
Date Initiated2019-12-02
Date Terminated2020-11-02
Product Quantity331
Reason for Recall
Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
Firm 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.
Root Cause
Packaging
Distribution Pattern
AL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.