CARDINAL HEALTH
Cardinal Health 200, LLC · Model BFM68 · UDI-DI 10885380065415
Description
Cardinal Health Silicone Bordered Foam 6 x 8in Dressing Partial to full thickness wounds: -Pressure ulcers -Traumatic wounds (eg. skin tears, road rash and minor injuries) -Diabetic, venous, and arterial ulcers -Graft and donor sites -Post-operative surgical wounds -Lacerations and abrasions Highly absorbent foam pad Gentle silicon adhesive Protective film backing Secure border Directions for use: 1. Clean wound with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Dry surrounding skin thoroughly. Skin barrier products are not necessary. 2. Remove dressing from packaging. 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. Do not stretch or cut product. 3. Apply adherent side of dressing over wound considering the overlap recommendations to protect the surrounding skin. Secondary dressing or additional fixation is not necessary. 3. 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 moderate to heavy exuding, partial to full thickness wounds, including: -Pressure ulcers -Traumatic wounds (eg. skin tears, road rash and minor injuries) -Diabetic, venous, and arterial ulcers -Graft and donor sites -Post-operative surgical wounds -Lacerations and abrasions
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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