Medela Invia Foam Dressing Kit Recalled for Packaging Defects
Medela Inc is recalling Invia Foam Dressing Kits with FitPad because holes in the sterile packaging may compromise sterility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medela Inc is recalling 331 units of the Invia Foam Dressing Kit with FitPad - X-Large (3 pcs), SKU # 0876224. The recall is due to a defect where the sterile packaging may contain holes, which could compromise the sterility of the medical device.
The affected product consists of a foam pad, a section interface (Invia FitPad), and Transparent Film. The recall covers specific lots with expiration dates ranging from November 2019 to November 2020. Distribution was limited to 16 states, including Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Minnesota, Missouri, North Carolina, New York, Pennsylvania, South Carolina, Tennessee, Texas, and Washington.
Consumers who have this product should stop using it and contact Medela Inc for further instructions or a replacement.
The recalled product
- 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).
- Manufacturer
- Medela Inc
- Category
- Medical Device — Wound Care
- Affected units
- 331
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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.
Distribution
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