FDA Device recall Z-1175-2025
3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus…
- FDA Device
- Class II
- ongoing
- Published 2025-02-26
On 2025-02-26 the FDA classified a Class II recall of 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus… by Kci Usa, citing due to increase in complaints related to leak alarms.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1175-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-17 |
| Published | 2025-02-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Kci Usa |
| Distribution | US |
Product
3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, US PRE4001AU PREVENA PLUS SYSTEM KIT, AU PRE4001CA PREVENA PLUS SYSTEM KIT, CA PRE4001UK PREVENA PLUS SYSTEM KIT, UK PRE4001US PREVENA PLUS SYSTEM KIT, US PRE4001 PREVENA PLUS SYSTEM KIT PRE4001ZA PREVENA PLUS SYSTEM KIT, ZA PRE4010 PREVENA PLUS STANDALONE EXTENDED LIFE SYSTEM KIT PRE5001 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 33X30 CM PRE5101 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 46X30 CM PRE5221 PREVENA RESTOR BELLA-FORM SYSTEM KIT 21X19 CM PRE5321 PREVENA RESTOR BELLA-FORM SYSTEM KIT 24X22 CM PRE5421 PREVENA RESTOR BELLA-FORM SYSTEM KIT 29X27 CM PRE5501 PREVENA RESTOR AXIO-FORM SYSTEM KIT 29X28 CM
Reason
Due to increase in complaints related to leak alarms
Identifiers
| code_info | PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US UDI-DI code: 00849554006744 Assembly Item number: PRE3021…PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US UDI-DI code: 00849554006744 Assembly Item number: PRE3021USV005 Lot Numbers: C16793V005 C17567V005 C18503V005 PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US UDI-DI code: 00849554006621 Assembly Item Number: PRE3201USV006 Lot Numbers: C16794V006 C17165V006 C17569V006 C17954V006 C18502V006 C18610V006 C19238V006 Assembly Item Number: PRE3201USV007 Lot Numbers: C18068V007 C18504V007 PRE3201 Prevena Plus Peel and Place 35 cm system Kit UDI-DI code: 00849554006645 Assembly Item Number: PRE3201V008 Lot Numbers: C17273V008 C17882V008 C18391V008 C19240V008 Assembly Item Number: PRE3201V009 Lot Numbers: C16796V009 C17755V009 C17955V009 Assembly Item Numbers: PRE3201V010 Lot Numbers: C16797V010 C17956V010 C18505V010 Assembly Item Number: PRE3201V011 Lot Numbers: C16798V011 C17957V011 C18506V011 PRE4000US Prevena Plus 125 Therapy Unit, US UDI-DI code: 00849554006768 Assembly Item Number: PRE4000USV005 Lot Numbers: C17175V |
|---|
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-1175-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.