KCI USA, INC.: 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 Pr

Hazard

Due to increase in complaints related to leak alarms

Details from the source

Reason for recall: Due to increase in complaints related to leak alarms 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, Fran Quantity: 135,268 Lot/code info: 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

UPC codes

00849554006744, 00849554006621, 00849554006645, 00849554006768, 00849554005877, 00849554005891, 00849554005907, 00849554005365, 00849554005884, 00849554007819, 50849554014096, 00849554014091, 50849554014102, 00849554014107, 50849554014119, 00849554014114, 50849554014126, 00849554014121, 50849554014133, 00849554014138, 50849554014140, 00849554014145, 50849554014355, 00849554014350, 00849554006805, 00849554007116, 00849554007154, 00849554007178, 00849554007130, 00849554007826

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.