FDA recall Z-0615-2021

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-11-05

Report date

2020-12-23

Termination date

2021-08-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

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