Z-0615-2021Class II

RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30...

Name: Z-0615-2021 RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30...
Creator: Medline Industries Inc
Published: 2020-11-05
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2020-11-05 / Terminated / root cause: packaging

FDA source

Medline Industries Inc began a recall of 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... on 2020-11-05. FDA classified it as Class II and gives the reason as "RevMedX Trauma Dressing is being recalled due to package seal integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0615-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-05
Posted: 2020-12-17
Terminated: 2021-08-04
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: NAB Gauze / Sponge,Nonresorbable For External Use
Reason for recall: RevMedX Trauma Dressing is being recalled due to package seal integrity.
Root cause tag: packaging
FDA root cause: Packaging
Action: Medline Industries, Inc. notified all affected consignees via first class mail on November 5, 2020 with a letter titled, "URGENT RECALL NOTIFICATION MEDLINE INDUSTRIES, INC. IMMEDIATE ACTION REQUIRED." Customers will be responsible for initiating sub-recall procedures. The required action's mentioned in the recall notification letter include: "1. Immediately check your stock for the affected item number and the affected lot numbers listed on the attachment. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indicated on the response form. When we receive your completed response form you will be sent return labels (if applicable). Your account will receive credit when the returned product is received. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, Inc."
Quantity in commerce: 15,780
Distribution: Worldwide distribution - US Nationwide distributions and the countries of Singapore, Denmark, Poland, Portugal, Kenya, Israel, and France.
Product codes and lots: Item Number: NONEX15182W Lot Number/Expiration Date: 38217080001, 08/2022; 38217080002, 08/2022; 38217070001, 07/2022; and 38218050002, 05/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0615-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0615-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-17

Product code NAB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)