CARDINAL HEALTH
Cardinal Health 200, LLC · Model FMTRACH · UDI-DI 10885380065323
Description
Cardinal Health Non-Adhesive Foam Tracheostomy 3.5 x 3.5in. Dressing Management of fluid, secretion, or exudate build-up for the peristomal area created by: -Tracheostomy tubes -Other drains and tubes Highly absorbent foam bad Protective film backing Non-adherent, fenestrated shape Directions for use: 1. Clean wound area with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Prepare and clean the skin surrounding the tracheostomy tube by removing excess moisture. 2. Remove dressing from packaging and fit dressing around the stoma or tracheostomy tube. Apply the white side towards the patient's skin. Dressing may be cut to shape for a better fit. 3. Additional fixation such as Cardinal Health Transparent Film or Tape may be used to secure the dressing. 4. All dressings should be monitored frequently. Dressings can be left in place for up to 7 days, or until visible drainage is 3/4 inch from the edge of the dressing. Remove dressing when clinically indicated, such as leakage or increased pain. Not made with natural rubber latex Indications Management of fluid, secretion or exudate build-up for the peristomal area created by: -Tracheostomy tubes -Other drains and tubes
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-29 | ConvaTec, Inc | Wound dressing may have foreign matter on the product. |
| 2025-02-19 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for the sterility of the device to be compromised. |
| 2022-01-28 | Sam Medical Products | Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered ov |
| 2021-08-20 | ConvaTec, Inc | Primary packaging labeling may be incorrect. |
| 2021-08-09 | ConvaTec, Inc | There is a potential for open seals which can compromise sterility. |
| 2018-08-01 | COVIDIEN LLC | Potential for product sterility breach due to a compromised or pinched seal defect |
| 2018-08-01 | COVIDIEN LLC | Potential for product sterility breach due to a compromised or pinched seal defect |
| 2018-08-01 | COVIDIEN LLC | Potential for product sterility breach due to a compromised or pinched seal defect |
| 2018-08-01 | COVIDIEN LLC | Potential for product sterility breach due to a compromised or pinched seal defect |
| 2018-08-01 | COVIDIEN LLC | Potential for product sterility breach due to a compromised or pinched seal defect |
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