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Class 2 Device Recall Invia Foam Dressing Kit with FitPad |
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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
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Product Classification |
negative pressure wound therapy Powered suction pump - Product Code OMP
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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
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For Additional Information Contact |
888-835-5968
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Manufacturer Reason for Recall |
Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
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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
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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.
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510(K) Database |
510(K)s with Product Code = OMP and Original Applicant = MEDELA, AG
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