FDAFDA · Food and drugs·Recall number Z-0615-2021
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.
Published December 23, 2020 · Recall initiated: November 5, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
RevMedX Trauma Dressing is being recalled due to package seal integrity.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medline Industries Inc
- Distributor
- Worldwide distribution - US Nationwide distributions and the countries of Singapore, Denmark, Poland, Portugal, Kenya, Israel, and France.
- Lot
- Item Number: NONEX15182W Lot Number/Expiration Date: 38217080001, 08/2022; 38217080002, 08/2022; 38217070001, 07/2022; and 38218050002, 05/2023
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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