FDA Medical devices recall ·
3M Prevena Plus 125 Therapy Unit and System Kits recall
- Recall number
- Z-1175-2025
- Date
- (initiated January 17, 2025)
- Company / brand
- Kci USA, Inc.
12930 W Interstate 10, San Antonio, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 135,268
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Due to increase in complaints related to leak alarms
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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: C17175V005 C17884V005 Assembly Item Number: PRE4000USV008 Lot Numbers: C16801V008 C16874V008 C16998V008 C17030V008 C17133V008 C17183V008 C17405V008 C17541V008 C17574V008 C17757V008 C17779V008 C17878V008 C17951V008 C18057V008 C18149V008 C18208V008 C18392V008 C18444V008 C18719V008 C18723V008 C18810V008 C18860V008 C18956V008 C19159V008 C19232V008 PRE4001AU PREVENA PLUS SYSTEM KIT, AU UDI-DI code: 00849554005877 Assembly Item Number: PRE4001AUV006 Lot Numbers: C16680V006 C17886V006 C18461V006 C18813V006 PRE40
Distribution
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Jordan, Kuwait, Mexico, Netherlands, New Zealand, Norway, Oman, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, UAE and UK.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1175-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.