Recall Z-0773-2020— Medela Inc

Name: FDA recall Z-0773-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-02

Class II · Terminated

Class II FDA medical device recall by Medela Inc, initiated 2019-12-02, terminated 2020-11-02. It names one FDA 510(k) clearance: K170088. 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: Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging..

Recalling firm: Medela Inc
Classification: Class II
Status: Terminated
Initiated: 2019-12-02
Terminated: 2020-11-02
Firm location: McHenry, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K170088 — Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent FilmMedela AG·cleared 2017-04-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.