FDA recall Z-0773-2020

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).

Reason for recall

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

Distribution

AL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA

Key facts

Status

Terminated

Initiation date

2019-12-02

Report date

2020-01-08

Termination date

2020-11-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

McHenry, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0773-2020