FDA Device recall Z-0507-2025
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound mana…
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound mana… by Kci Usa, citing due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0507-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-05 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Kci Usa |
| Distribution | US |
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.
Reason
Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
Identifiers
| code_info | Model Number: CAPULTDEV01/BR.S UDI-DI codes: 00849554000636 00849554000636 00849554001084 Serial Numbers: GAAC06245 GA…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 GAA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0507-2025%22
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