FDA-Device2020-12-23Class II

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.

Medline Industries Inc
Hazard

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

Sold states
Worldwide distribution - US Nationwide distributions and the countries of Singapore, Denmark, Poland, Portugal, Kenya, Israel, and France.
Affected count
15,780
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0615-2021

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