FDA Medical Device Recalls (openFDA)
Medela Inc: 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).
- Recall number
- Z-0773-2020
- Recalling firm
- Medela Inc
- 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).
- Status
- Terminated
- Initiated
- 2019-12-02
- Posted
- not on file
- Terminated
- 2020-11-02
- Reason
- Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
- 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 medelareturns@medela.com or call 888-835-5968.
- Quantity
- 331
- Distribution
- AL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K170088"]
- PMA numbers
- not on file
- Product code
- OMP
- Firm FEI
- 1419937
- Firm city
- McHenry
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28