Recall Z-0507-2025
Kci USA, Inc. · initiated November 5, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
Codes / lots: Model Number: CAPULTDEV01/BR.S UDI-DI codes: 00849554000636 00849554000636 00849554001084 Serial Numbers: GAAC06245 GAAC06246 GAAC06247 GAAC06248 GAAC06249 GAAC06250 GAAC06251 GAAC06252 GAAC06253 GAAC06254 GAAC06255 GAAC06256 GAAC06257 GAAC06258 GAAC06259 GAAC06260 GAAC06261 GAAC06262 GAAC06263 GAAC06264 GAAC06265 GAAC06266 GAAC06267 GAAC06268 GAAC06269 GAAC06270 GAAC06271 GAAC06272 GAAC06273 GAAC06274 GAAC06275 GAAC06276 GAAC06277 GAAC06278 GAAC06279 GAAC06280 GAAC06281 GAAC06282 GAAC06283 GAAC06284 GAAC06285 GAAC06286 GAAC06287 GAAC06288 GAAC06289 GAAC06290 GAAC06291 GAAC06292 GAAC06293 GAAC06294 GAAC06295 GAAC06296 GAAC06297 GAAC06298 GAAC06299 GAAC06300 GAAC06301 GAAC06302 GAAC06303 GAAC06304 GAAC06305 GAAC06306 GAAC06307 GAAC06308 GAAC06309 GAAC06310 GAAC06311 GAAC06312 GAAC06313 GAAC06314 GAAC06315 GAAC06316 GAAC06317 GAAC06318 GAAC06319 GAAC06320 GAAC06321 GAAC06322 GAAC06323 GAAC06324 GAAC06863 GAAC06864 GAAC06865 GAAC06866 GAAC06867 GAAC06868 GAAC06869 GAAC06870 GAAC06871 GAAC06872 GAAC06873 GAAC06874 GAAC06875 GAAC06876 GAAC06877 GAAC06878 GAAC06879 GAAC06880 GAAC06881 GAAC06882 GAAC06883 GAAC06884 GAAC06885 GAAC06886 GAAC06887 GAAC06888 GAAC06889 GAAC06890 GAAC06891…
Reason for recall
Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
FDA-determined cause: Use error
Action taken
On 11/05/2024, the firm sent an "URGENT - MEDICAL DEVICE CORRECTION" Letter to customers informing them that due to a potentially broken occlusion sensor that the Veraflo instillation therapy units may encounter a System Error 007 alarm during boot up which may delay therapy. Customer are instructed to: 1. Locate all serial numbers and Therapy Unit Software version of V.A.C. Ulta Therapy Units. 2. Perform the steps outlined in the attached test procedure for the occlusion detection sensor 3. Record the test results on the provided Field Notice Receipt and Customer Response Form. Complete all remaining fields, sign and return this form via email to kci3mfieldactionresponse@solventum.com. Additional copies of the response form may be required based on the number of units in your facility. 4. For any therapy units with a FAIL test result, contact your Solventum representative to coordinate the repair/replacement of the occlusion detection sensor with your facility. If any additional issues are identified during the repair, you will be notified, and it will be the responsibility of the unit owner to determine whether to proceed with the additional services and associated costs. 5. Post this Medical Device Correction letter on or near the affected products to ensure continuous reminders of the field corrective action. For questions or assistance, contact Solventum representative, visit Solventum.com or call 800-275-4524.
Details
- Recall number
- Z-0507-2025
- Initiated
- November 5, 2024
- Posted by FDA
- November 22, 2024
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Quantity
- 83,721 devices
- Distribution
- Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY O.U.S.(foreign) countries to: Australia, Estonia, Italy, Norway, Spain, Austria, Finland, Japan, Oman, Sweden, Bahrain, France, Jordan, Philippines…
- Recalling firm
- Kci USA, Inc., San Antonio, TX