CARDINAL HEALTH
Cardinal Health 200, LLC · Model FM66 · UDI-DI 10885380065293
Description
Cardinal Health Silicone Foam 6 x 6in. Dressing Partial to full thickness wounds: -Pressure ulcers -Traumatic wounds (eg. skin tears and secondary healing wounds) -Graft and donor sites -Post-operative surgical wounds -Diabetic, venous, and arterial ulcers Highly absorbent foam pad Gentle silicone adhesive Protective film backing Directions for use: 1. Clean wound with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Dry surrounding skin thoroughly. 2. Remove dressing from packaging and if necessary cut dressing to size. For dressings smaller than 5x5 inches, there should be a 3/4-inch overlap onto the dry skin surrounding the wound. For dressings larger than 5x5 inches, there should be a 2-inch overlap. 3. Affix dressing over wound considering the overlap recommendations to protect the surrounding skin. 4. If necessary, cover this primary dressing with a moisture retentive secondary dressing to protect and promote a moist wound healing environment. 5. All dressings should be monitored frequently. Remove dressing when clinically indicated, such as leakage or increased pain, or after a maximum of 7 days. Not made with natural rubber latex Indications: May be used for the management of moderately exuding, partial to full thickness wounds, including: -Pressure ulcers -Traumatic wounds (eg. skin tears and secondary healing wounds) -Graft and donor sites -Post-operative surgical wounds -Diabetic, venous, and arterial ulcers
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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