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RecallWatchMedical Device Safety
Class IIOngoingZ-1175-2025

KCI USA, INC. recalls 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel…

KCI USA, INC.San Antonio, TX, United StatesReported Feb 26, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Due to increase in complaints related to leak alarms

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI code
    337 affected lots
    C16793V005C17567V005C18503V005PRE3201US00849554006621PRE3201USV006C16794V006C17165V006
    +329 moreC17569V006C17954V006C18502V006C18610V006C19238V006PRE3201USV007C18068V007C18504V007PRE320100849554006645PRE3201V008C17273V008C17882V008C18391V008C19240V008PRE3201V009C16796V009C17755V009C17955V009PRE3201V010C16797V010C17956V010C18505V010PRE3201V011C16798V011C17957V011C18506V011PRE4000US12500849554006768PRE4000USV005C17175V005C17884V005PRE4000USV008C16801V008C16874V008C16998V008C17030V008C17133V008C17183V008C17405V008C17541V008C17574V008C17757V008C17779V008C17878V008C17951V008C18057V008C18149V008C18208V008C18392V008C18444V008C18719V008C18723V008C18810V008C18860V008C18956V008C19159V008C19232V008PRE4001AU00849554005877PRE4001AUV006C16680V006C17886V006C18461V006C18813V006PRE4001CA00849554005891PRE4001CAV006C17683V006C17818V006C19162V006PRE4001UK00849554005907PRE4001UKV006C17024V006C17177V006C17300V006C17958V006PRE4001US00849554005365PRE4001USV005C18959V005PRE4001USV006C16753V006C16802V006C16875V006C16999V006C17032V006C17129V006C17184V006C17258V006C17303V006C17406V006C17565V006C17576V006C17780V006C17879V006C17952V006C18058V006C18205V006C18227V006C18394V006C18466V006C18721V006C18725V006C18812V006C18862V006C18958V006C19060V006C19161V006C19234V006PRE4001PRE4001V006C17178V006C18062V006C18814V006PRE4001V008C18523V008PRE4001ZA00849554005884PRE4001ZAV006C18060V006C18464V006PRE401000849554007819PRE4010V001C16715V001C16883V001C17000V001C17031V001C17134V001C17195V001C17257V001C17302V001C17407V001C17542V001C17575V001C17758V001C17781V001C17880V001C17953V001C18059V001C18150V001C18209V001C18393V001C18465V001C18720V001C18724V001C18811V001C18861V001C18957V001C19059V001C19160V001PRE4010V003C16878V003PRE4010V004C16879V004C17684V004PRE4010V005C17007V005C17534V005C17959V005PRE4010V007C18815V007PRE4010V0165084955401409600849554014091C16880V016C17179V016C17685V016C17960V016C18445V016C18816V016PRE4010V0175084955401410200849554014107C16881V017C17180V017C17304V017C17686V017C17961V017C18446V017C18817V017PRE4010V018PRE4010V0185084955401411900849554014114C18077V018C18863V018PRE4010V019PRE4010V0195084955401412600849554014121C17181V019C17687V019C18447V019PRE4010V020PRE4010V0205084955401413300849554014138C16882V020C17182V020C17307V020C17688V020C18061V020C18448V020C18818V020PRE4010V021PRE4010V0215084955401414000849554014145C17305V021C18819V021PRE4010V023PRE4010V0235084955401435500849554014350C18820V023PRE500133X3000849554006805PRE5001V001C16928V001C17196V001C17759V001C18578V001C18625V001C19061V001PRE5001V002C16748V002C17760V002PRE5001V003C16749V003C16929V003PRE5001V004C16750V004C18626V004C19062V004PRE5001V005C16930V005C17761V005C18069V005PRE510146X3000849554007116PRE5101V001C17762V001PRE5101V002C17763V002PRE5101V003C17219V003PRE5101V004C17765V004C18070V004PRE5101V005C18072V005C18627V005PRE522121X1900849554007154PRE5221V001C18579V001C18628V001C19064V001PRE5221V002C16931V002C17220V002PRE5221V004C18580V004C18782V004C19066V004PRE5221V005C17221V005C17767V005C18783V005PRE532124X2200849554007178PRE5321V001C18612V001C18803V001PRE5321V002C18613V002C18613V002PRE5321V003C16751V003C18614V003PRE5321V004C18615V004C19538V004PRE5321V005C18616V005PRE542129X2700849554007130PRE5421V001C16932V001C17222V001C17768V001C18073V001C18581V001C18784V001C19067V001PRE5421V002C16933V002C17223V002PRE5421V003C17224V003C17770V003C18074V003C18583V003PRE5421V004C16752V004C16934V004C17225V004C17771V004C18584V004PRE5421V005C18585V005C19068V005PRE550129X2800849554007826PRE5501V001C16935V001C18076V001C18586V001PRE6001

What the firm is doing

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 kci3mfieldactionresponse@solventum.com. 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.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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