—#184475

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.

FDA product code: NAB — Gauze / Sponge,Nonresorbable For External Use
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Item Number: NONEX15182W Lot Number/Expiration Date: 38217080001, 08/2022; 38217080002, 08/2022; 38217070001, 07/2022; and 38218050002, 05/2023

Why it was recalled

RevMedX Trauma Dressing is being recalled due to package seal integrity.

Root cause (FDA determination)

Packaging

Action the firm took

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."

Recalling firm

Firm: Medline Industries Inc
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distributions and the countries of Singapore, Denmark, Poland, Portugal, Kenya, Israel, and France.

Timeline

Recall initiated: 2020-11-05
Terminated: 2021-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184475. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.