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Thin H Compression Bandage, Standard Fold

H&H MEDICAL CORPORATION · Model 1 · UDI-DI 00857048006101

FQM

510(k) clearances

299

Adverse events

Recalls

698

Facilities

Description

Based on the proven design of the H-Bandage compression dressing, the Thin H Bandage combines a 4" x 7.5" thick ABD pad with a strong elastic strap and the patented H-cleat compression device. The H-cleat allows first responders to deliver pressure down onto a wound to control bleeding and protect the wounded area. The H&H Thin H comes in a sterile, vacuum-sealed 5 mil barrier bag, in either a flat fold or a standard fold to create a small tight package. This gives users choices regarding which version to pack in their kit. The Thin H is popular in small kits, small vacuum-sealed packs, and as a stand-alone product.

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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.