# FDA recall Z-0615-2021

> **Medline Industries Inc** · Class II · device recall initiated 2020-11-05.

## 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

- **Recall number:** Z-0615-2021
- **Recalling firm:** Medline Industries Inc
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0615-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0615-2021. Source: US FDA. Licensed CC0.

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