Device Recall Elctrocardiograph Electrodes

  • Modelo / Serial
    List of models and lot numbers - USA Artikel No. Brand / Model Lot Nos. Skintact W-60 (30/1200) 58051 Skintact W-60 (30/1200) 31113-0159 58051 Skintact W-60 (30/1200) 40304-0324 58051 Skintact W-60 (30/1200) 40325-0153 58051 Skintact W-60 (30/1200) 40326-0154 58051 Skintact W-60 (30/1200) 40416-0326 S&W; 620 58205 S&W; 620 31121-0155 58205 S&W; 620 31122-0156 58205 S&W; 620 31125-0159 58205 S&W; 620 40730-0324 58205 S&W; 620 40901-0328 58205 S&W; 620 50723-0326 58205 S&W; 620 50827-0329 Stable Base SBW55 50007 Stable Base SBW55 31104-0159 50007 Stable Base SBW55 31107-0321 50007 Stable Base SBW55 31108-0322 50007 Stable Base SBW55 31108-0323 50007 Stable Base SBW55 31111-0324 50007 Stable Base SBW55 31118-0325 50007 Stable Base SBW55 31119-0326 50007 Stable Base SBW55 31120-0327 50007 Stable Base SBW55 31121-0328 50007 Stable Base SBW55 31121-0329 50007 Stable Base SBW55 31122-0321 50007 Stable Base SBW55 31125-0322 50007 Stable Base SBW55 31129-0323 50007 Stable Base SBW55 31202-0324 50007 Stable Base SBW55 31203-0325 50007 Stable Base SBW55 40107-0323 50007 Stable Base SBW55 40107-0324 50007 Stable Base SBW55 40108-0325 50007 Stable Base SBW55 40109-0326 50007 Stable Base SBW55 40225-0157 50007 Stable Base SBW55 40226-0158 50007 Stable Base SBW55 40227-0151 50007 Stable Base SBW55 40227-0159 50007 Stable Base SBW55 40228-0152 50007 Stable Base SBW55 40303-0153 50007 Stable Base SBW55 40304-0154 50007 Stable Base SBW55 40304-0155 50007 Stable Base SBW55 40305-0156 Page 1 of 4 50007 Stable Base SBW55 40306-0157 50007 Stable Base SBW55 40307-0158 50007 Stable Base SBW55 40310-0159 50007 Stable Base SBW55 40311-0151 50007 Stable Base SBW55 40422-0328 50007 Stable Base SBW55 40428-0329 50007 Stable Base SBW55 40430-0321 50007 Stable Base SBW55 40505-0322 50007 Stable Base SBW55 40508-0323 50007 Stable Base SBW55 40512-0324 50007 Stable Base SBW55 40616-0152 50007 Stable Base SBW55 40618-0153 50007 Stable Base SBW55 40623-0154 50007 Stable Base SBW55 40625-0155 50007 Stable Base SBW55 40626-0156 50007 Stable Base SBW55 40630-0157 50007 Stable Base SBW55 40701-0158 50007 Stable Base SBW55 40703-0159 50007 Stable Base SBW55 40705-0151 50007 Stable Base SBW55 40708-0152 50007 Stable Base SBW55 40711-0153 50007 Stable Base SBW55 40714-0154 50007 Stable Base SBW55 40715-0155 50007 Stable Base SBW55 40717-0156 50007 Stable Base SBW55 40721-0157 50007 Stable Base SBW55 40722-0158 50007 Stable Base SBW55 40724-0159 50007 Stable Base SBW55 40725-0151 50007 Stable Base SBW55 40728-0152 50007 Stable Base SBW55 40731-0154 50007 Stable Base SBW55 40804-0155 50007 Stable Base SBW55 40805-0156 50007 Stable Base SBW55 40806-0157 50007 Stable Base SBW55 40808-0158 50007 Stable Base SBW55 40811-0159 50007 Stable Base SBW55 40812-0151 50007 Stable Base SBW55 40818-0152 50007 Stable Base SBW55 40819-0153 50007 Stable Base SBW55 40822-0154 50007 Stable Base SBW55 40825-0155 50007 Stable Base SBW55 40826-0157 50007 Stable Base SBW55 40828-0158 50007 Stable Base SBW55 40901-0159 50007 Stable Base SBW55 40902-0151 50007 Stable Base SBW55 40903-0152 50007 Stable Base SBW55 40903-0153 50007 Stable Base SBW55 40904-0154 50007 Stable Base SBW55 40908-0155 50007 Stable Base SBW55 40909-0156 50007 Stable Base SBW55 40911-0157 50007 Stable Base SBW55 40913-0158 50007 Stable Base SBW55 40925-0157 50007 Stable Base SBW55 40927-0158 50007 Stable Base SBW55 40930-0159 50007 Stable Base SBW55 41010-0323 50007 Stable Base SBW55 41013-0156 50007 Stable Base SBW55 41013-0324 50007 Stable Base SBW55 41015-0157 50007 Stable Base SBW55 41015-0325 50007 Stable Base SBW55 41016-0158 50007 Stable Base SBW55 41016-0326 50007 Stable Base SBW55 41017-0159 50007 Stable Base SBW55 41020-0151 50007 Stable Base SBW55 41021-0152 50007 Stable Base SBW55 41106-0152 50007 Stable Base SBW55 41107-0153 50007 Stable Base SBW55 41111-0154 50007 Stable Base SBW55 41113-0155 50007 Stable Base SBW55 41114-0156 50007 Stable Base SBW55 41117-0157 50007 Stable Base SBW55 50609-0152 50007 Stable Base SBW55 50610-0153 50007 Stable Base SBW55 50611-0154 50007 Stable Base SBW55 50615-0155 50007 Stable Base SBW55 50617-0156 50007 Stable Base SBW55 50618-0157 50007 Stable Base SBW55 50709-0158 50007 Stable Base SBW55 50710-0159 50007 Stable Base SBW55 50714-0151 50007 Stable Base SBW55 50715-0152 50007 Stable Base SBW55 50717-0153 50007 Stable Base SBW55 50720-0154 50007 Stable Base SBW55 50818-0151 50007 Stable Base SBW55 50820-0152 50007 Stable Base SBW55 50824-0153 50007 Stable Base SBW55 50826-0154 50007 Stable Base SBW55 50827-0155 50007 Stable Base SBW55 50828-0156 50007 Stable Base SBW55 50901-0157 50007 Stable Base SBW55 50910-0153 50007 Stable Base SBW55 50914-0154 50007 Stable Base SBW55 50916-0155 50007 Stable Base SBW55 50918-0156 50007 Stable Base SBW55 50921-0157 50007 Stable Base SBW55 50923-0158 Stable Base SBW55-15 50675 Stable Base SBW55-15 40729-0153 50675 Stable Base SBW55-15 41008-0154 50675 Stable Base SBW55-15 41009-0155 50675 Stable Base SBW55-15 50213-0321 50675 Stable Base SBW55-15 50218-0322 50675 Stable Base SBW55-15 50327-0156 50675 Stable Base SBW55-15 50401-0157 50675 Stable Base SBW55-15 50403-0158 50675 Stable Base SBW55-15 50408-0159 50675 Stable Base SBW55-15 50409-0151 50675 Stable Base SBW55-15 50902-0158 50675 Stable Base SBW55-15 50903-0159 50675 Stable Base SBW55-15 50907-0151 50675 Stable Base SBW55-15 50908-0152 Stable Base SBT60 50547 Stable Base SBT60 40314-0155 50547 Stable Base SBT60 40317-0156   List of models and lot numbers - outside USA Artikel No. Brand / Model Lot Nos. Skintact W-60HP E3 50476 Skintact W-60HP E3 31106-0246 50476 Skintact W-60HP E3 40226-0248 50476 Skintact W-60HP E3 40307-0249 50476 Skintact W-60HP E3 40324-0247 50476 Skintact W-60HP E3 50204-0247 50476 Skintact W-60HP E3 50601-0246 Skintact T-60 58046 Skintact T-60 40312-0329 58046 Skintact T-60 40313-0321 58046 Skintact T-60 40314-0322 Skintact W-60 (30/1200) 58051 Skintact W-60 (30/1200) 31106-0152 58051 Skintact W-60 (30/1200) 31106-0153 58051 Skintact W-60 (30/1200) 31113-0158 58051 Skintact W-60 (30/1200) 31125-0158 58051 Skintact W-60 (30/1200) 31127-0151 58051 Skintact W-60 (30/1200) 31210-0321 58051 Skintact W-60 (30/1200) 31211-0322 58051 Skintact W-60 (30/1200) 31216-0158 58051 Skintact W-60 (30/1200) 31216-0159 58051 Skintact W-60 (30/1200) 40305-0325 58051 Skintact W-60 (30/1200) 40402-0159 58051 Skintact W-60 (30/1200) 40403-0151 58051 Skintact W-60 (30/1200) 40414-0324 58051 Skintact W-60 (30/1200) 40414-0325 58051 Skintact W-60 (30/1200) 40417-0327 58051 Skintact W-60 (30/1200) 40430-0156 58051 Skintact W-60 (30/1200) 40602-0326 58051 Skintact W-60 (30/1200) 40722-0328 58051 Skintact W-60 (30/1200) 40918-0321 58051 Skintact W-60 (30/1200) 41001-0326 58051 Skintact W-60 (30/1200) 41106-0329 58051 Skintact W-60 (30/1200) 41107-0321 58051 Skintact W-60 (30/1200) 41118-0325 58051 Skintact W-60 (30/1200) 41121-0327 58051 Skintact W-60 (30/1200) 50206-0327 58051 Skintact W-60 (30/1200) 50210-0328 58051 Skintact W-60 (30/1200) 50325-0155 58051 Skintact W-60 (30/1200) 50409-0329 58051 Skintact W-60 (30/1200) 50430-0329 58051 Skintact W-60 (30/1200) 50527-0322 58051 Skintact W-60 (30/1200) 50625-0322 58051 Skintact W-60 (30/1200) 50626-0323 58051 Skintact W-60 (30/1200) 50701-0324 58051 Skintact W-60 (30/1200) 50702-0325 58051 Skintact W-60 (30/1200) 50708-0327 Skintact W-60 (30/1200/4800) 58995 Skintact W-60 (30/1200/4800) 31112-0157 58995 Skintact W-60 (30/1200/4800) 40221-0153 58995 Skintact W-60 (30/1200/4800) 40430-0155 58995 Skintact W-60 (30/1200/4800) 50123-0159 58995 Skintact W-60 (30/1200/4800) 50901-0322 Skintact W-60 (30/300/1800) 59356 Skintact W-60 (30/300/1800) 31107-0154 59356 Skintact W-60 (30/300/1800) 31108-0155 59356 Skintact W-60 (30/300/1800) 31202-0154 59356 Skintact W-60 (30/300/1800) 40108-0153 59356 Skintact W-60 (30/300/1800) 40109-0154 59356 Skintact W-60 (30/300/1800) 40129-0152 59356 Skintact W-60 (30/300/1800) 40218-0159 59356 Skintact W-60 (30/300/1800) 40303-0323 59356 Skintact W-60 (30/300/1800) 40321-0151 59356 Skintact W-60 (30/300/1800) 40324-0152 59356 Skintact W-60 (30/300/1800) 40331-0158 59356 Skintact W-60 (30/300/1800) 40410-0323 59356 Skintact W-60 (30/300/1800) 40514-0327 59356 Skintact W-60 (30/300/1800) 40604-0327 59356 Skintact W-60 (30/300/1800) 40708-0322 59356 Skintact W-60 (30/300/1800) 40709-0323 59356 Skintact W-60 (30/300/1800) 40806-0329 59356 Skintact W-60 (30/300/1800) 40915-0329 59356 Skintact W-60 (30/300/1800) 41021-0329 59356 Skintact W-60 (30/300/1800) 41030-0325 59356 Skintact W-60 (30/300/1800) 41215-0329 59356 Skintact W-60 (30/300/1800) 50108-0158 59356 Skintact W-60 (30/300/1800) 50109-0159 59356 Skintact W-60 (30/300/1800) 50112-0151 59356 Skintact W-60 (30/300/1800) 50204-0326 59356 Skintact W-60 (30/300/1800) 50305-0326 59356 Skintact W-60 (30/300/1800) 50306-0327 59356 Skintact W-60 (30/300/1800) 50413-0321 59356 Skintact W-60 (30/300/1800) 50519-0327 59356 Skintact W-60 (30/300/1800) 50623-0159 59356 Skintact W-60 (30/300/1800) 50625-0151 59356 Skintact W-60 (30/300/1800) 50706-0326 59356 Skintact W-60 (30/300/1800) 50903-0326 59356 Skintact W-60 (30/300/1800) 50904-0327 Patz K920 58198 Patz K920 40219-0151 58198 Patz K920 40220-0152 58198 Patz K920 40808-0321 58198 Patz K920 50120-0157 58198 Patz K920 50917-0326 Dahlhausen 1900000440 58688 Dahlhausen 1900000440 31209-0329 58688 Dahlhausen 1900000440 40116-0151 58688 Dahlhausen 1900000440 40217-0158 58688 Dahlhausen 1900000440 40317-0323 58688 Dahlhausen 1900000440 40407-0329 58688 Dahlhausen 1900000440 40516-0328 58688 Dahlhausen 1900000440 40627-0326 58688 Dahlhausen 1900000440 40827-0327 58688 Dahlhausen 1900000440 40930-0325 58688 Dahlhausen 1900000440 41103-0326 58688 Dahlhausen 1900000440 41216-0321 58688 Dahlhausen 1900000440 50122-0158 58688 Dahlhausen 1900000440 50508-0323 58688 Dahlhausen 1900000440 50713-0329 58688 Dahlhausen 1900000440 50831-0321 Cardionetics CN-15-W60 59629 Cardionetics CN-15-W60 40115-0159 59629 Cardionetics CN-15-W60 40327-0155 59629 Cardionetics CN-15-W60 40606-0328 59629 Cardionetics CN-15-W60 41023-0321 59629 Cardionetics CN-15-W60 50119-0156 59629 Cardionetics CN-15-W60 50407-0326 59629 Cardionetics CN-15-W60 50812-0322 Lessa 99.832.02 58789 Lessa 99.832.02 40314-0097 58789 Lessa 99.832.02 40725-0093 EF Medica FS 50 LG 58872 EF Medica FS 50 LG 40307-0091 Ultragel FS50LG 50359 Ultragel FS50LG 40304-0098
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the state of : FL., and to the countries of : Australia, Austria, Croatia, Czech Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Malta, Norway, Poland, Portugal, Romania, Serbia, Spain, Switzerland, Thailand, Turkey and United Arab Emirates.
  • Descripción del producto
    ECG Electrodes: || 50007  Stablebase SBW55 || 50675  Stablebase SBW55-15 || 58051  Skintact W-60 || 50547  Stablebase SBT60 || Only OUS: || 50476 Skintact W-60HP E3 I || 58046 Skintact T-60 I Patz K920 || 58688 Dahlhausen 1900000440 || 59629 Cardionetics CN-15-W60 || 58789 Lessa 99.832.02 || 58872 EF Medica FS 50 LG || 50359Ultragel FS50LG
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Leonhard Lang Medizintechnik GmbH, Archenweg 56, Innsbruck Austria
  • Source
    USFDA