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U.S. Department of Health and Human Services

Class 2 Device Recall RevMedX Trauma Dressing

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  Class 2 Device Recall RevMedX Trauma Dressing see related information
Date Initiated by Firm November 05, 2020
Create Date December 17, 2020
Recall Status1 Terminated 3 on August 04, 2021
Recall Number Z-0615-2021
Recall Event ID 86764
Product Classification Gauze / sponge,nonresorbable for external use - Product Code NAB
Product RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Product Usage: are intended to absorb exudates.
Code Information Item Number: NONEX15182W Lot Number/Expiration Date: 38217080001, 08/2022; 38217080002, 08/2022; 38217070001, 07/2022; and 38218050002, 05/2023
Recalling Firm/
Manufacturer		 Medline Industries Inc
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact
866-359-1704
Manufacturer Reason
for Recall		 RevMedX Trauma Dressing is being recalled due to package seal integrity.
FDA Determined
Cause 2		 Packaging
Action Medline Industries, Inc. notified all affected consignees via first class mail on November 5, 2020 with a letter titled, "URGENT RECALL NOTIFICATION MEDLINE INDUSTRIES, INC. IMMEDIATE ACTION REQUIRED." Customers will be responsible for initiating sub-recall procedures. The required action's mentioned in the recall notification letter include: "1. Immediately check your stock for the affected item number and the affected lot numbers listed on the attachment. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indicated on the response form. When we receive your completed response form you will be sent return labels (if applicable). Your account will receive credit when the returned product is received. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, Inc."
Quantity in Commerce 15,780
Distribution Worldwide distribution - US Nationwide distributions and the countries of Singapore, Denmark, Poland, Portugal, Kenya, Israel, and France.
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.
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