Reported Feb 26, 2025 · Ongoing
3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US…
Kci USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: KCI USA, INC. · 12930 W Interstate 10 · San Antonio, TX · 78249-2248
Is this the product you have?
- 3M Prevena Plus 125
- Therapy Unit and System Kits REFPRE3021US 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
- Lot codes and dates
109 of 109 products
Products covered by this recall Model / number Barcodes Product as published PRE3021USV005— — 00849554006621Lot Numbers: C16793V005 C17567V005 C18503V005 PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US UDI-DI code: 00849554006621 Assembly PRE3201USV006— — Lot Numbers: C16794V006 C17165V006 C17569V006 C17954V006 C18502V006 C18610V006 C19238V006 Assembly PRE3201USV007— — 00849554006645Lot Numbers: C18068V007 C18504V007 PRE3201 Prevena Plus Peel and Place 35 cm system Kit UDI-DI code: 00849554006645 Assembly PRE3201V008— — Lot Numbers: C17273V008 C17882V008 C18391V008 C19240V008 Assembly PRE3201V009— — Lot Numbers: C16796V009 C17755V009 C17955V009 Assembly — Item Numbers: PRE3201V010 — Lot Numbers: C16797V010 C17956V010 C18505V010 Assembly PRE3201V011— — 00849554006768Lot Numbers: C16798V011 C17957V011 C18506V011 PRE4000US Prevena Plus 125 Therapy Unit, US UDI-DI code: 00849554006768 Assembly PRE4000USV005— — Lot Numbers: C17175V005 C17884V005 Assembly PRE4000USV008— — 00849554005877Lot 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 PRE4001AUV006— — 00849554005891Lot Numbers: C16680V006 C17886V006 C18461V006 C18813V006 PRE4001CA PREVENA PLUS SYSTEM KIT, CA UDI-DI code: 00849554005891 Assembly - Amount recalled
- 135,268
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Due to increase in complaints related to leak alarms
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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