BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-1175-2025 · Initiated January 17, 2025

    Recall

    Recall Number
    Z-1175-2025
    Event Number
    96070
    Firm
    KCI USA, INC.
    FEI Number
    3009897021
    Product Code
    QFC
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    January 17, 2025
    Posted
    February 14, 2025
    Address
    12930 W Interstate 10, San Antonio, TX, 78249-2248

    Description

    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

    Action

    On 01/17/2025, the firm sent an "URGENT - MEDICAL DEVICE RECALL" Letter via US Postal to customers informing them that Solventum has identified that devices distributed between March 11, 2024 and November 18th, 2024 were released with a leak alarm threshold lower than the design specification. This results in the therapy unit prematurely alarming although there is no leak within the system and potentially continuing to alarm during therapy although there is no visible leak. Customers are instructed to: 1.Screen their facility or other storage locations for the impacted products and lot numbers listed in Attachment 1. 2.Immediately cease use and quarantine any identified product. 3.Complete the Field Notice Receipt and Customer Response Form acknowledging that they have received a copy of this notice and select one of two options: a.Acknowledge they do not have any product impacted by the field action. b.Acknowledge they have product impacted by the field action and complete the catalog number, lot numbers and quantities they have identified and quarantined. 4.Return the form via email to [email protected]. 5.Call Solventum customer service at 1-800-275-4524 to help coordinate the return shipment and receive return labels. 6.Products returned to Solventum will be assessed, reprogrammed, and returned or replaced. a.Product skus and quantities shipped to Solventum will be returned or replaced with the same quantities. b.Returned or replaced product will have a visual identifier confirming the assessment and reprogramming. c.Returned or replaced product may have different lot numbers and expiry dates; Solventum plans to ship available product to help reduce wait times. For any questions, please contact your local Solventum representative, visit Solventum.com or call 800-275-4524.

    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.

    Quantity

    135,268