Recall Z-2542-2020 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
KCI USA, INC.
ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closur
| Date | Jun 8, 2020 |
| Status | Terminated |
| Reason | The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy. |
| Root cause | Under Investigation by firm |
| Action | For Customer Owned units, KCI plans to notify customers via customer letters delivered by common carriers or via email communication that the ACTIV.A.C." Therapy Unit may shut down without notification to the user. The customer letter notification or email communication will inform customers to coordinate the product software change. The recalling firm sent an URGENT - MEDICAL DEVICE RECALL letter to the affected customers on 06/08/2020. The completed Customer Response Form is to be returned to kci3mfieldactionresponse@mmm.com |
| Quantity | 5,823 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AZ, FL, IL, OH, MD, ND, NV, OK, SC, TN, TX, UT, VA, WA and Puerto Rico. The country of Australia, Austria, Canada, China, France, Germany, Japan, Hong Kong, India, Indonesia, Malaysia, New Zealand, Philippines, South Kor |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183543 | ACTIV.A.C. Therapy Unit Kci USA, Inc., Mar 20, 2019 |