Reported Dec 4, 2024 · Ongoing
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an…
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?
- V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
- Lot codes and dates
- Model NumberCAPULTDEV01/BR
- S UDI-DI codes00849554000636 00849554000636 00849554001084
- Serial Numbers
2,133 of 2,133 codes
GAAC06245GAAC06246GAAC06247GAAC06248GAAC06249GAAC06250GAAC06251GAAC06252GAAC06253GAAC06254GAAC06255GAAC06256GAAC06257GAAC06258GAAC06259GAAC06260GAAC06261GAAC06262GAAC06263GAAC06264GAAC06265GAAC06266GAAC06267GAAC06268GAAC06269GAAC06270GAAC06271GAAC06272GAAC06273GAAC06274GAAC06275GAAC06276GAAC06277GAAC06278GAAC06279GAAC06280GAAC06281GAAC06282GAAC06283GAAC06284GAAC06285GAAC06286GAAC06287GAAC06288GAAC06289GAAC06290GAAC06291GAAC06292GAAC06293GAAC06294GAAC06295GAAC06296GAAC06297GAAC06298GAAC06299GAAC06300GAAC06301GAAC06302GAAC06303GAAC06304
- VFVS03820 VFVS03821 Model NumberCAPULTDEV01/CZ
- S UDI-DI codesSerial
- Numbers
135 of 135 codes
GAAC07371GAAC07372GAAC07373GAAC07374GAAC07375GAAC07376GAAC07377GAAC07378GAAC07379GAAC07380GAAC07381GAAC07382GAAC07383GAAC07384GAAC13283GAAC13284GAAC13285GAAC13286GAAC13287GAAC13288GAAC13289GAAC13290GAAC13291GAAC13292GAAC13293GAAC13294GAAC13295GAAC13296GAAC13297GAAC13298GAAC13299GAAC15282GAAC15283GAAC15284GAAC15285GAAC15286GAAC15287GAAC15288GAAC15289GAAC15290GAAC15291GAAC15292GAAC15293GAAC15294GAAC15295GAAC15296GAAC15297GAAC15298GAAC15299GAAC15300GAAC15301GAAC15302GAAC15303GAAC15304GAAC15305GAAC15306GAAC15307GAAC15308GAAC15309GAAC15310
- VFVS14588 VFVS14589 Model NumberCAPULTDEV01/HR
- S UDI-DI codesSerial
- Numbers
GAAC20103GAAC20423GAAC20424GAAC20425GAAC20426GAAC20427GAAC20428GAAC20429GAAC20430GAAC20431GAAC20432GAAC20442GAAC22296GAAC22297GAAC22298GAAC22299GAAC22300GAAC22301GAAC22302GAAC22303GAAC22304GAAC22305GAAC22306GAAC22307GAAC22308GAAC22309GAAC22310GAAC22311GAAC22312GAAC22313GAAC22314GAAC22315GAAC22316GAAC22317GAAC22318GAAC22319GAAC22320GAAC22321GAAC22322GAAC22323GAAC22324GAAC23431GAAC23432GAAC23854GAAC23855VFVS00016VFVS01190VFVS01191VFVS01192VFVS02208VFVS02209VFVS03418VFVS03429VFVS17641VFVS17642VFVS17643
- VFVS17644 VFVS17645 Model NumberCAPULTDEV01/HU
- S UDI-DI codesSerial
- NumbersGAAC18978 GAAC18982 GAAC18983 GAAC18984 GAAC18985
- VFVS14597 VFVS14598 Model NumberCAPULTDEV01/ID
- S UDI-DI codesSerial
- Numbers
GAAC18969GAAC18970GAAC19194GAAC19195GAAC19196GAAC19197GAAC21542GAAC21543GAAC21544GAAC21545GAAC21546GAAC21547GAAC21548GAAC21549GAAC21550GAAC21551GAAC21552GAAC21553GAAC21800GAAC21801GAAC21802GAAC21803GAAC21804GAAC21805GAAC21806GAAC23826GAAC23827GAAC23828GAAC23829GAAC23830GAAC23831GAAC23832GAAC23833GAAC23834GAAC23835GAAC23836GAAC23837GAAC23838GAAC23839GAAC23840GAAC23841GAAC23842GAAC23843GAAC23844GAAC23845GAAC23846GAAC23847GAAC23848GAAC23849GAAC23850GAAC23851
- GAAC23852 GAAC23853 Model NumberCAPULTDEV01/PL
- S UDI-DI codesSerial
- Numbers
599 of 599 codes
GAAC05311GAAC05312GAAC05313GAAC05794GAAC05795GAAC05796GAAC05797GAAC05798GAAC05799GAAC05800GAAC05801GAAC05802GAAC05803GAAC05804GAAC05805GAAC06225GAAC06226GAAC06227GAAC06228GAAC06229GAAC06230GAAC06231GAAC06232GAAC06233GAAC06234GAAC08064GAAC08065GAAC08066GAAC08067GAAC08068GAAC08069GAAC08070GAAC08071GAAC08072GAAC08073GAAC08074GAAC08075GAAC08076GAAC08077GAAC08078GAAC08079GAAC08080GAAC08081GAAC08082GAAC08083GAAC08084GAAC08085GAAC08086GAAC08087GAAC08088GAAC08089GAAC08090GAAC08091GAAC08092GAAC08093GAAC08094GAAC08095GAAC08096GAAC08097GAAC08098
- VFVS17033 VFVS17034 Model NumberCAPULTDEV01/RO
- S UDI-DI codesSerial
- Numbers
98 of 98 codes
GAAC06235GAAC06236GAAC06237GAAC06238GAAC06239GAAC06240GAAC06241GAAC06242GAAC06243GAAC06244GAAC08219GAAC08220GAAC08221GAAC08222GAAC08223GAAC08224GAAC08225GAAC08226GAAC08227GAAC08228GAAC08229GAAC08230GAAC08231GAAC08232GAAC08233GAAC08234GAAC08235GAAC08236GAAC08237GAAC08238GAAC08239GAAC08240GAAC08241GAAC08242GAAC08243GAAC08244GAAC08245GAAC08246GAAC08247GAAC08248GAAC08249GAAC08250GAAC08251GAAC08252GAAC08253GAAC08254GAAC08255GAAC08256GAAC08257GAAC08258GAAC08259GAAC08260GAAC08261GAAC08262GAAC08263GAAC08264GAAC08265GAAC08266GAAC08267GAAC08268
- VFVS17019 VFVS17020 Model NumberCAPULTDEV01/SI
- S UDI-DI codesSerial
- Numbers
115 of 115 codes
GAAC07385GAAC07386GAAC07387GAAC07388GAAC07389GAAC07390GAAC07391GAAC07392GAAC07393GAAC07394GAAC07395GAAC07396GAAC07397GAAC07398GAAC07399GAAC07400GAAC07401GAAC07402GAAC07403GAAC07404GAAC07405GAAC07406GAAC07407GAAC07408GAAC07409GAAC07410GAAC07411GAAC07412GAAC07413GAAC07414GAAC08184GAAC08185GAAC08186GAAC08187GAAC08188GAAC08189GAAC08190GAAC08191GAAC08192GAAC08193GAAC08194GAAC08195GAAC08196GAAC08197GAAC08198GAAC08199GAAC08200GAAC08201GAAC08202GAAC08203GAAC08204GAAC08205GAAC08206GAAC08207GAAC08208GAAC18770GAAC18771GAAC18772GAAC18773GAAC18776
- Amount recalled
- 83,721 devices
Where it was sold
Why it was recalled
Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
This product could cause temporary or reversible health problems — stop using it.
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