Device 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.
Z-0615-2021
Product summary
- Event
- Event 86764
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,780
- Official record key
device-enforcement:Z-0615-2021
Official wording
Reason: RevMedX Trauma Dressing is being recalled due to package seal integrity.
Code information: Item Number: NONEX15182W Lot Number/Expiration Date: 38217080001, 08/2022; 38217080002, 08/2022; 38217070001, 07/2022; and 38218050002, 05/2023
Distribution pattern: Worldwide distribution - US Nationwide distributions and the countries of Singapore, Denmark, Poland, Portugal, Kenya, Israel, and France.
Derived failure modes
-
Unknown
RevMedX Trauma Dressing is being recalled due to package seal integrity.