Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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.

U.S. FDA — Device Enforcement · United States · 2020-11-05 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0615-2021
Date of alert: 2020-11-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medline Industries Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 38217080001

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall 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.

Related