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HemCon® OneStop™ Bandage, 2in x 2in
TRICOL BIOMEDICAL, INC. · Model 1 · UDI-DI 00870053000353
FRO
Prescription
10
510(k) clearances
3,166
Adverse events (64 deaths)
82
Recalls
385
Facilities
Description
The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to the wound, the dressing controls bleeding. The dressing offers an antibacterial barrier against a wide range of gram positive and gram negative organisms, including antibiotic resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. Only single strains of most species mentioned have been studied.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-08 | ConvaTec, Inc | Surgical dressing manufactured out of specification (greater thickness). |
| 2026-04-27 | Oculus Technologies of Mexico, S.A. de C.V. | The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the produc |
| 2026-01-16 | Integra LifeSciences Corp. (NeuroSciences) | Potential packaging failures, which could lead to a breach in the sterile barrier. |
| 2026-01-16 | Integra LifeSciences Corp. (NeuroSciences) | Potential packaging failures, which could lead to a breach in the sterile barrier. |
| 2026-01-16 | Integra LifeSciences Corp. (NeuroSciences) | Potential packaging failures, which could lead to a breach in the sterile barrier. |
| 2026-01-05 | Medline Industries, LP | Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for |
| 2026-01-05 | Medline Industries, LP | Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for |
| 2025-08-05 | Integra LifeSciences Corp. (NeuroSciences) | Packaging failures were identified which could lead to a breach in the sterile barrier. |
| 2025-08-05 | Integra LifeSciences Corp. (NeuroSciences) | Packaging failures were identified which could lead to a breach in the sterile barrier. |
| 2025-08-05 | Integra LifeSciences Corp. (NeuroSciences) | Packaging failures were identified which could lead to a breach in the sterile barrier. |
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Get your free API keyRead the docsData 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.