iTClamp®
INNOVATIVE TRAUMA CARE INC · Model 9200 · UDI-DI 00854874004035
Description
The iTClamp® quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The iTClamp® is a self-locking trauma clamp with needles that penetrate the skin to evert the skin edges between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal. The iTClamp Model 9200 is a non-sterile training product, not for clinical use.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-15 | Maquet Cardiovascular, LLC | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartst |
| 2025-08-15 | Maquet Cardiovascular, LLC | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartst |
| 2025-08-15 | Maquet Cardiovascular, LLC | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartst |
| 2025-07-01 | North American Rescue LLC. | Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device a |
| 2024-02-22 | Baxter Healthcare Corporation | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe |
| 2024-02-22 | Baxter Healthcare Corporation | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe |
| 2024-02-22 | Baxter Healthcare Corporation | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe |
| 2023-12-06 | Baxter Healthcare Corporation | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the produ |
| 2023-12-06 | Baxter Healthcare Corporation | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the produ |
| 2022-04-01 | Baxter Healthcare Corporation | There is a potential for foreign matter. |
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