Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-0615-2021

November 05, 2020

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 86764
Status
Terminated
Classification
Class II
Quantity
15,780
Official record key
device-enforcement:Z-0615-2021

Official wording

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

Code information: Item Number: NONEX15182W Lot Number/Expiration Date: 38217080001, 08/2022; 38217080002, 08/2022; 38217070001, 07/2022; and 38218050002, 05/2023

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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