Z-0773-2020Class II

Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad...

Name: Z-0773-2020 Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad...
Creator: Medela Inc
Published: 2019-12-02
License: https://open.fda.gov/license/

Medela AG / initiated 2019-12-02 / Terminated / root cause: packaging

FDA source

Medela Inc began a recall of 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... on 2019-12-02. FDA classified it as Class II and gives the reason as "Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0773-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-02
Posted: 2020-01-02
Terminated: 2020-11-02
Recalling firm: Medela AG
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).
Product code: OMP Negative Pressure Wound Therapy Powered Suction Pump
Reason for recall: Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
Root cause tag: packaging
FDA root cause: Packaging
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.
Quantity in commerce: 331
Distribution: AL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0773-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0773-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-08	2020-01-02

Product code OMP

K170088Class IIInvia 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

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)