Z-0615-2021 Class II Terminated
FDA device recall Z-0615-2021 was initiated by Medline Industries Inc on November 5, 2020 and is designated Class II. Reason for recall: RevMedX Trauma Dressing is being recalled due to package seal integrity. The recall status is terminated (terminated August 4, 2021). Affected quantity: 15,780.
Recall Details
- Product Type
- Devices
- Report Date
- December 23, 2020
- Initiation Date
- November 5, 2020
- Termination Date
- August 4, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,780
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.
Distribution Pattern
Worldwide distribution - US Nationwide distributions and the countries of Singapore, Denmark, Poland, Portugal, Kenya, Israel, and France.
Code Information
Item Number: NONEX15182W Lot Number/Expiration Date: 38217080001, 08/2022; 38217080002, 08/2022; 38217070001, 07/2022; and 38218050002, 05/2023