CONTROL WRAP, 4"
TACTICAL MEDICAL SOLUTIONS, LLC · Model A · UDI-DI 00818630010319
Description
Tactical Medical Solutions® designed the Control Wrap to make life a little easier when under stress. Just as in our OLAES® and BLAST® Bandages, we incorporate a series of brakes into each elastic bandage. These brakes prevent accidental un-rolling during application. The brakes also provide grip surfaces during the wrapping process and assist in maintaining the desired pressure and position of the bandage. This is extremely helpful when changing angles during the wrapping process or if bandaging awkward injuries. By reducing the risk of accidental unrolling of the bandage, you minimize the following risks: Contaminating a clean bandage Waste of a bandage due to contamination Lost time while managing loose ends Loss of pressure after applying the bandage due to shifting of material Unrolled bandage dimensions: 4" or 6" x 48"
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-27 | Medline Industries, LP | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. |
| 2025-03-03 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2024-04-02 | Andover Healthcare Inc. | A packaging seal gap could impact the sterility of the product. |
| 2022-06-22 | ASO LLC | The product falls apart during handling after removal from its primary packaging. |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2022-02-01 | BSN Medical Inc | The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled. |
| 2020-08-21 | North American Rescue LLC. | Lack of sterility assurance of the 30-0171 |
| 2019-06-19 | Andover Healthcare Inc. | Incomplete packaging seal of sterile product |
| 2019-06-19 | Andover Healthcare Inc. | Incomplete packaging seal of sterile product |
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