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 details

Manufacturer

KCI USA, INC.

Distributor

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.

Lot

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 PRE4001CA PREVENA PLUS SYSTEM KIT, CA UDI-DI code: 00849554005891 Assembly Item Number: PRE4001CAV006 Lot Numbers: C17683V006 C17818V006 C19162V006 PRE4001UK PREVENA PLUS SYSTEM KIT, UK UDI-DI code: 00849554005907 Assembly Item Number: PRE4001UKV006 Lot Numbers: C17024V006 C17177V006 C17300V006 C17958V006 PRE4001US PREVENA PLUS SYSTEM KIT, US UDI-DI code: 00849554005365 Assembly Item Number: PRE4001USV005 Lot Number: C18959V005 Assembly Item Number: PRE4001USV006 Lot Numbers: C16753V006 C16802V006 C16875V006 C16999V006 C17032V006 C17129V006 C17184V006 C17258V006 C17303V006 C17406V006 C17565V006 C17576V006 C17780V006 C17879V006 C17952V006 C18058V006 C18205V006 C18227V006 C18394V006 C18466V006 C18721V006 C18725V006 C18812V006 C18862V006 C18958V006 C19060V006 C19161V006 C19234V006 PRE4001 PREVENA PLUS SYSTEM KIT Assembly Item Number: PRE4001V006 Lot Numbers: C17178V006 C18062V006 C18814V006 Assembly Item Number: PRE4001V008 Lot Number: C18523V008 PRE4001ZA PREVENA PLUS SYSTEM KIT, ZA UDI-DI code: 00849554005884 Assembly Item Number: PRE4001ZAV006 Lot Numbers: C18060V006 C18464V006 PRE4010 PREVENA PLUS STANDALONE EXTENDED LIFE SYSTEM KIT UDI-DI code: 00849554007819 Assembly Item Number: PRE4010V001 Lot Numbers: C16715V001 C16883V001 C17000V001 C17031V001 C17134V001 C17195V001 C17257V001 C17302V001 C17407V001 C17542V001 C17575V001 C17758V001 C17781V001 C17880V001 C17953V001 C18059V001 C18150V001 C18209V001 C18393V001 C18465V001 C18720V001 C18724V001 C18811V001 C18861V001 C18957V001 C19059V001 C19160V001 Assembly Item Number: PRE4010V003 Lot Number: C16878V003 Assembly Item Number: PRE4010V004 Lot Numbers: C16879V004 C17684V004 Assembly Item Number: PRE4010V005 Lot Numbers: C17007V005 C17534V005 C17959V005 Assembly Item Number: PRE4010V007 Lot Number: C18815V007 Assembly Number: PRE4010V016 UDI-DI codes: Shipper: 50849554014096, Primary Box: 00849554014091 Lot Numbers: C16880V016 C17179V016 C17685V016 C17960V016 C18445V016 C18816V016 Assembly Item Number: PRE4010V017 UDI-DI Codes: Shipper: 50849554014102, Primary Box: 00849554014107 Lot Numbers: C16881V017 C17180V017 C17304V017 C17686V017 C17961V017 C18446V017 C18817V017 Assembly Item Number: PRE4010V018 UDI-DI codes: PRE4010V018 - Shipper: 50849554014119, Primary Box: 00849554014114 Lot Numbers: C18077V018 C18863V018 Assembly Item Number: PRE4010V019 UDI-DI codes: PRE4010V019 - Shipper: 50849554014126, Primary Box: 00849554014121 Lot Numbers: C17181V019 C17687V019 C18447V019 Assembly Item Number: PRE4010V02

Risk classification

Class II

Area (FDA)

device

Country

United States