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Kci USA, Inc. FDA Recalls
3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PClass IIJan 17, 2025Due to increase in complaints related to leak alarms |
| 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.AClass IIJan 17, 2025Due to increase in complaints related to leak alarms |
| V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is anClass IINov 5, 2024Due to potential system error alarm and the inability to ini |