Recall Z-0615-2021— Medline Industries Inc

Class II · Terminated

Class II FDA medical device recall by Medline Industries Inc, initiated 2020-11-05, terminated 2021-08-04. FDA's recall record names no specific 510(k) clearance for this event. 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: RevMedX Trauma Dressing is being recalled due to package seal integrity..

Recalling firm
Medline Industries Inc
Classification
Class II
Status
Terminated
Initiated
2020-11-05
Terminated
2021-08-04
Firm location
Northfield, IL, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.