Recall Z-0615-2021 ยท NAB Gauze / Sponge,Nonresorbable For External Use
Medline Industries Inc
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.
| Date | Nov 5, 2020 |
| Status | Terminated |
| Reason | RevMedX Trauma Dressing is being recalled due to package seal integrity. |
| 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. |
| Quantity | 15,780 |
| Distribution | Worldwide distribution - US Nationwide distributions and the countries of Singapore, Denmark, Poland, Portugal, Kenya, Israel, and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.