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.
Reported: December 23, 2020 Initiated: November 5, 2020 #Z-0615-2021
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.
Details
- Recalling Firm
- Medline Industries Inc
- Units Affected
- 15,780
- Distribution
- Worldwide distribution - US Nationwide distributions and the countries of Singapore, Denmark, Poland, Portugal, Kenya, Israel, and France.
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medline Industries Inc. Units affected: 15,780.
Why was this product recalled? ▼
RevMedX Trauma Dressing is being recalled due to package seal integrity.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 23, 2020. Severity: Moderate. Recall number: Z-0615-2021.
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