H-Bandage Compression Dressing, Flat Fols
H&H MEDICAL CORPORATION · Model 1 · UDI-DI 00857048006095
Description
The H-Bandage is the latest in Universal Severe Trauma Dressings. An upgrade to our patented combat dressing Cinch Tight, the H-Bandage gives medics and field personnel both an emergency dressing and a hemostat for arterial bleeding and hemorrhaging in limbs. The H-Bandage’s unique design allows for one-handed use under any condition. Designed for First Responders, Military, and Law Enforcement, the H-Bandage provides a fast, effective tool for all kinds of serious traumas and injuries involving arterial bleeding. The unique design of the H-Bandage, with its 8 in thick ABD pad and the unique 5 foot elastic wrap designed for both strength and flexibility along with the H-shaped cinch sewn into the bandage, allows it to satisfy multiple field needs. The H-shaped cinch allows for direct pressure to be applied directly on top of a wound, increasing compression and reducing blood loss.
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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