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U.S. Department of Health and Human Services

Class 2 Device Recall Invia Foam Dressing Kit with FitPad

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  Class 2 Device Recall Invia Foam Dressing Kit with FitPad see related information
Date Initiated by Firm December 02, 2019
Create Date January 02, 2020
Recall Status1 Terminated 3 on November 02, 2020
Recall Number Z-0773-2020
Recall Event ID 84368
510(K)Number K170088  
Product Classification negative pressure wound therapy Powered suction pump - Product Code OMP
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).
Code Information 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.
Recalling Firm/
Manufacturer		 Medela Inc
1101 Corporate Dr
McHenry IL 60050-7006
For Additional Information Contact
888-835-5968
Manufacturer Reason
for Recall		 Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
FDA Determined
Cause 2		 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 in Commerce 331
Distribution AL, AZ, CA, CO, FL, GA, IL, MN, MO, NC, NY, PA, SC, TN, TX, WA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OMP and Original Applicant = MEDELA, AG
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