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.
Check against the official notice below — it lists the full affected range.
Medline Industries Inc is recalling RevMedX Trauma Dressings due to package seal integrity issues. The affected product consists of sterile trauma dressings designed to absorb exudate, packaged individually in Tyvek peel pouches with 30 pouches per case. A total of 15,780 units have been recalled, with lot numbers 38217080001 and 38217080002 (expiring August 2022), lot number 38217070001 (expiring July 2022), and lot number 38218050002 (expiring May 2023), identified by item number NONEX15182W.
The affected products were distributed worldwide, including throughout the United States and in Singapore, Denmark, Poland, Portugal, Kenya, Israel, and France. The source document does not specify what consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
RevMedX Trauma Dressing is being recalled due to package seal integrity.
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. Quantity: 15,780 Lot/code info: Item Number: NONEX15182W Lot Number/Expiration Date: 38217080001, 08/2022; 38217080002, 08/2022; 38217070001, 07/2022; and 38218050002, 05/2023
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.