CLASS II Device recall · Reported 19 Aug 2015 · FDA Enforcement Report

Invacare¿ Pronto¿ Air Personal Transporter recalled

Invacare is recalling Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, distributed nationwide in the US. The recall was initiated on 2 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel #AIRPTMBDY18, Serial #s: 12JSZD60025, 12JSZD60026, 12JSZD60027, 12KSZD60001, 12KSZD60002, 12KSZD60004, 12KSZD60005, 12KSZD60006, 12KSZD60007, 12KSZD60008, 12KSZD60010, 12KSZD60013, 12KSZD60014, 12KSZD60015, 12KSZD60016, 12KSZD60017, 12KSZD60018, 12KSZD60019, 12KSZD60020, 12KSZD60021, 12KSZD60022, 12KSZD60023, 12KSZD60024, 12KSZD60026, 12KSZD60028, 12KSZD60029, 12KSZD60030, 12KSZD60031, 12KSZD60032, 12KSZD60033, 12KSZD60034, 12KSZD60035, 12KSZD60036, 12KSZD60037, 12KSZD60038, 12KSZD60039, 12KSZD60040, 12KSZD60041, 12KSZD60042, 12KSZD60043, 12KSZD60045, 12KSZD60046, 12KSZD60047, 12KSZD60048, 12KSZD60049, 12KSZD60050, 12KSZD60051, 12KSZD60052, 12KSZD60053, 12KSZD60054, 12KSZD60055, 12KSZD60056, 12KSZD60057, 12KSZD60058, 12KSZD60059, 12KSZD60060, 12KSZD60061, 12KSZD60063, 12KSZD60064, 12KSZD60065, 12KSZD60066, 12KSZD60067, 12KSZD60069, 12KSZD60070, 12KSZD60071, 12KSZD60072, 12KSZD60073, 12KSZD60075, 12KSZD60076, 12KSZD60077, 12KSZD60078, 12KSZD60079, 12KSZD60080, 12KSZD60081, 12KSZD60082, 12KSZD60083, 12KSZD60085, 12KSZD60086, 12KSZD60087, 12KSZD60088, 12KSZD60091, 12KSZD60092, 12KSZD60093, 12KSZD60094, 12KSZD60095, 12KSZD60096, 12KSZD60098, 12KSZD60099, 12KSZD60100, 12KSZD60101, 12KSZD60103, 12KSZD60105, 12KSZD60107, 12KSZD60108, 12KSZD60109, 12KSZD60110, 12KSZD60111, 12KSZD60112, 12KSZD60114, 12KSZD60115, 12KSZD60116, 12KSZD60117, 12KSZD60118, 12KSZD60120, 12KSZD60121, 12KSZD60122, 12KSZD60123, 12KSZD60124, 12KSZD60125, 12KSZD60126, 12KSZD60127, 12KSZD60128, 12KSZD60129, 12KSZD60130, 12KSZD60131, 12KSZD60134, 12KSZD60136, 12KSZD60137, 12KSZD60138, 12KSZD60139, 12KSZD60140, 12KSZD60141, 12KSZD60142, 12KSZD60143, 12KSZD60144, 12KSZD60145, 12KSZD60146, 12KSZD60147, 12KSZD60148, 12KSZD60149, 12KSZD60151, 12KSZD60152, 12KSZD60153, 12KSZD60154, 12KSZD60155, 12KSZD60156, 12KSZD60158, 12KSZD60159, 12KSZD60160, 12KSZD60162, 12KSZD60163, 12KSZD60164, 12KSZD60165, 12KSZD60166, 12KSZD60168, 12KSZD60169, 12KSZD60170, 12KSZD60171, 12KSZD60172, 12KSZD60173, 12KSZD60174, 12KSZD60176, 12KSZD60177, 12KSZD60178, 12KSZD60179, 12KSZD60180, 12KSZD60181, 12KSZD60182, 12KSZD60183, 12KSZD60186, 12KSZD60187, 12KSZD60188, 12KSZD60189, 12KSZD60190, 12KSZD60191, 12KSZD60192, 12KSZD60193, 12KSZD60194, 12KSZD60195, 12KSZD60197, 12KSZD60198, 12KSZD60199, 12KSZD60200, 12KSZD60201, 12KSZD60203, 12KSZD60204, 12KSZD60205, 12KSZD60206, 12KSZD60207, 12KSZD60209, 12KSZD60211, 12KSZD60212, 12KSZD60213, 12KSZD60214, 12KSZD60215, 12KSZD60216, 12KSZD60217, 12KSZD60219, 12KSZD60220, 12LSZD60001, 12LSZD60002, 12LSZD60003, 12LSZD60004, 12LSZD60006, 12LSZD60007, 12LSZD60008, 12LSZD60009, 12LSZD60011, 12LSZD60012, 12LSZD60014, 12LSZD60015, 12LSZD60017, 12LSZD60018, 12LSZD60020, 12LSZD60021, 12LSZD60024, 12LSZD60025, 12LSZD60026, 12LSZD60027, 12LSZD60028, 12LSZD60029, 12LSZD60030, 12LSZD60031, 12LSZD60032, 12LSZD60033, 12LSZD60034, 12LSZD60035, 12LSZD60036, 12LSZD60037, 12LSZD60040, 12LSZD60042, 12LSZD60043,12LSZD60044, 12LSZD60046, 12LSZD60047, 12LSZD60048, 12LSZD60049, 12LSZD60050, 12LSZD60051, 12LSZD60052, 12LSZD60053, 12LSZD60054,12LSZD60055, 12LSZD60056, 12LSZD60058, 12LSZD60059, 12LSZD60063, 12LSZD60064, 12LSZD60067, 12LSZD60068, 12LSZD60069, 12LSZD60070, 12LSZD60071, 12LSZD60072, 12LSZD60073, 12LSZD60074, 12LSZD60075, 12LSZD60076, 12LSZD60077, 12LSZD60078, 12LSZD60079, 12LSZD60080, 12LSZD60081, 12LSZD60083, 12LSZD60084, 12LSZD60085, 12LSZD60086, 12LSZD60088, 12LSZD60089, 12LSZD60091, 12LSZD60093, 12LSZD60094, 12LSZD60095, 12LSZD60096, 12LSZD60097, 12LSZD60098, 12LSZD60099, 12LSZD60100, 12LSZD60101, 12LSZD60102, 12LSZD60103, 12LSZD60104, 12LSZD60105, 12LSZD60107, 12LSZD60109, 12LSZD60110, 12LSZD60112, 12LSZD60113, 12LSZD60114, 12LSZD60115, 12LSZD60116, 12LSZD60117, 12LSZD60121, 12LSZD60122, 12LSZD60123, 12LSZD60124, 12LSZD60126, 12LSZD60127, 12LSZD60128, 12LSZD60129, 12LSZD60130, 12LSZD60131, 12LSZD60132, 12LSZD60134, 12LSZD60135, 12LSZD60136, 12LSZD60137, 12LSZD60139, 12LSZD60140, 12LSZD60141, 12LSZD60142, 12LSZD60144, 12LSZD60145, 12LSZD60146, 12LSZD60147, 12LSZD60149, 12LSZD60150, 12LSZD60151, 12LSZD60152, 12LSZD60155, 12LSZD60156, 12LSZD60158, 12LSZD60159, 12LSZD60160, 12LSZD60161, 12LSZD60162, 12LSZD60163, 12LSZD60164, 12LSZD60167, 12LSZD60168, 12LSZD60169, 12LSZD60170, 12LSZD60171, 12LSZD60172, 12LSZD60173, 12LSZD60174, 12LSZD60175, 12LSZD60176, 12LSZD60177, 12LSZD60178, 12LSZD60181, 12LSZD60182, 12LSZD60185, 12LSZD60187, 12LSZD60190, 12LSZD60192, 12LSZD60193, 12LSZD60194, 12LSZD60195, 12LSZD60197, 12LSZD60198, 12LSZD60199, 12LSZD60200, 12LSZD60201, 12LSZD60202, 12LSZD60203, 12LSZD60205, 12LSZD60206, 12LSZD60207, 12LSZD60208, 12LSZD60209, 12LSZD60210, 12LSZD60211, 12LSZD60212, 12LSZD60213, 12LSZD60214, 12LSZD60215, 12LSZD60216, 13CSZD60001, 13CSZD60002, 13CSZD60003, 13CSZD60004, 13CSZD60005, 13CSZD60006, 13CSZD60008, 13CSZD60009, 13CSZD60011, 13CSZD60013, 13CSZD60015, 13CSZD60016, 13CSZD60018, 13CSZD60019, 13CSZD60022, 13CSZD60023, 13CSZD60024, 13CSZD60025, 13CSZD60026, 13CSZD60028, 13CSZD60029, 13CSZD60031, 13CSZD60032, 13CSZD60034, 13CSZD60035, 13CSZD60036, 13CSZD60037, 13CSZD60039, 13CSZD60040, 13CSZD60041, 13CSZD60042, 13CSZD60044, 13CSZD60045, 13CSZD60046, 13CSZD60047, 13CSZD60048, 13CSZD60050, 13CSZD60051, 13CSZD60052, 13CSZD60054, 13CSZD60055, 13CSZD60056, 13CSZD60057, 13CSZD60058, 13CSZD60059, 13CSZD60066, 13CSZD60071, 13CSZD60072, 13CSZD60074, 13CSZD60075, 13CSZD60076, 13CSZD60077, 13CSZD60078, 13CSZD60079, 13CSZD60080, 13CSZD60082, 13CSZD60083, 13CSZD60084, 13CSZD60085, 13CSZD60087, 13CSZD60088, 13CSZD60091, 13CSZD60093, 13CSZD60095, 13CSZD60097, 13CSZD60098, 13CSZD60099, 13CSZD60100, 13CSZD60101, 13CSZD60102, 13CSZD60103, 13CSZD60104, 13CSZD60105, 13CSZD60107, 13CSZD60108, 13CSZD60110, 13CSZD60112, 13CSZD60113, 13CSZD60114, 13CSZD60115, 13CSZD60116, 13CSZD60117, 13CSZD60118, 13CSZD60119, 13CSZD60128, 13CSZD60130, 13CSZD60131, 13CSZD60133, 13CSZD60134, 13CSZD60135, 13CSZD60136, 13CSZD60138, 13CSZD60140, 13CSZD60141, 13CSZD60144, 13CSZD60146, 13CSZD60147, 13CSZD60148, 13CSZD60149, 13CSZD60150, 13CSZD60151, 13CSZD60153, 13CSZD60154, 13CSZD60155, 13CSZD60156, 13CSZD60157, 13CSZD60159, 13CSZD60163, 13CSZD60164, 13CSZD60166, 13CSZD60167, 13CSZD60168, 13CSZD60170, 13CSZD60171, 13CSZD60173, 13CSZD60175, 13CSZD60178, 13CSZD60180, 13CSZD60182, 13CSZD60183, 13CSZD60188, 13CSZD60189, 13CSZD60191, 13CSZD60193, 13CSZD60194, 13CSZD60198. 13CSZD60199, 13CSZD60200, 13CSZD60201, 13CSZD60203, 13CSZD60204, 13CSZD60205, 13CSZD60207, 13CSZD60208, 13CSZD60211, 13CSZD60213, 13CSZD60214, 13CSZD60215, 13CSZD60216, 13CSZD60219, 13CSZD60224, 13CSZD60225, 13CSZD60227, 13CSZD60229, 13DSZD60001, 13DSZD60002, 13DSZD60003, 13DSZD60004, 13DSZD60005, 13DSZD60007, 13DSZD60008, 13DSZD60010, 13DSZD60012, 13DSZD60013, 13DSZD60015, 13DSZD60016, 13DSZD60017, 13DSZD60019, 13DSZD60020, 13DSZD60021, 13DSZD60023, 13DSZD60024, 13DSZD60026, 13DSZD60027, 13DSZD60029, 13DSZD60030, 13DSZD60032, 13DSZD60033, 13DSZD60034, 13DSZD60035, 13DSZD60036, 13DSZD60037, 13DSZD60039, 13DSZD60040, 13DSZD60041, 13DSZD60042, 13DSZD60043, 13DSZD60044, 13DSZD60045, 13DSZD60046, 13DSZD60047, 13DSZD60055, 13DSZD60056, 13DSZD60057, 13DSZD60058, 13DSZD60059, 13DSZD60060, 13DSZD60061, 13DSZD60062, 13DSZD60065, 13DSZD60066, 13DSZD60067, 13DSZD60068, 13DSZD60069, 13DSZD60074, 13DSZD60075, 13DSZD60076, 13DSZD60077, 13DSZD60078, 13DSZD60079, 13DSZD60080, 13DSZD60081, 13DSZD60082, 13DSZD60084, 13DSZD60085, 13DSZD60086, 13DSZD60087, 13DSZD60088, 13DSZD60089, 13DSZD60091, 13DSZD60092, 13DSZD60095, 13DSZD60096, 13DSZD60097, 13DSZD60098, 13DSZD60099, 13DSZD60100, 13DSZD60101, 13DSZD60102, 13DSZD60103, 13DSZD60104, 13DSZD60105, 13DSZD60107, 13DSZD60108, 13DSZD60109, 13DSZD60110, 13ESZD60002, 13ESZD60003, 13ESZD60004, 13ESZD60005, 13ESZD60007, 13ESZD60008, 13ESZD60009, 13ESZD60010, 13ESZD60011l, 13ESZD60012, 13ESZD60014, 13ESZD60015, 13ESZD60016, 13ESZD60017, 13ESZD60018, 13ESZD60019, 13ESZD60020, 13ESZD60021, 13ESZD60022, 13ESZD60023, 13ESZD60024, 13ESZD60025, 13ESZD60027, 13ESZD60030, 13ESZD60031, 13ESZD60032, 13ESZD60033, 13ESZD60034, 13ESZD60035, 13ESZD60036, 13ESZD60037, 13ESZD60038, 13ESZD60039, 13ESZD60040, 13ESZD60041, 13FSZD60001, 13FSZD60002, 13FSZD60003, 13FSZD60004, 13FSZD60005, 13FSZD60006, 13FSZD60009, 13FSZD60011, 13FSZD60012, 13FSZD60013, 13FSZD60014, 13FSZD60015, 13FSZD60016, 13FSZD60017, 13FSZD60018, 13FSZD60019, 13FSZD60020, 13FSZD60021, 13FSZD60022, 13FSZD60023, 13FSZD60024, 13FSZD60025, 13FSZD60027, 13FSZD60030, 13FSZD60031, 13FSZD60032, 13FSZD60033, 13FSZD60034, 13FSZD60035, 13FSZD60036, 13FSZD60037, 13FSZD60040, 13FSZD60041, 13FSZD60042, 13FSZD60043, 13FSZD60044, 13FSZD60045, 13FSZD60048, 13FSZD60049, 13FSZD60050, 13FSZD60051, 13FSZD60052, 13FSZD60053,13FSZD60054, 13FSZD60055, 13FSZD60056, 13FSZD60057, 13FSZD60058, 13FSZD60060, 13FSZD60061, 13FSZD60062, 13FSZD60063, 13FSZD60064, 13FSZD60067, 13FSZD60068, 13FSZD60069, 13FSZD60070, 13FSZD60071, 13FSZD60072, 13FSZD60075, 13FSZD60076, 13FSZD60078, 13FSZD60079, 13FSZD60080, 13FSZD60081, 13FSZD60082, 13FSZD60084, 13FSZD60085, 13FSZD60086, 13FSZD60088, 13FSZD60089, 13FSZD60094, 13FSZD60096, 13FSZD60097, 13FSZD60098, 13FSZD60100, 13FSZD60101, 13FSZD60102,13FSZD60103, 13FSZD60104, 13FSZD60106, 13FSZD60107, 13FSZD60111, 13FSZD60112, 13FSZD60114, 13FSZD60115, 13FSZD60118, 13FSZD60119, 13FSZD60120, 13FSZD60121, 13GSZD60001, 13GSZD60003, 13GSZD60004, 13GSZD60006, 13GSZD60007, 13GSZD60010, 13GSZD60011, 13GSZD60013, 13GSZD60014, 13GSZD60015, 13GSZD60016, 13GSZD60017, 13GSZD60018, 13GSZD60019, 13GSZD60022, 13GSZD60023, 13GSZD60024, 13GSZD60025, 13GSZD60026, 13GSZD60027, 13GSZD60030, 13GSZD60031, 13GSZD60032, 13GSZD60033, 13GSZD60036, 13GSZD60037, 13GSZD60038, 13GSZD60040, 13GSZD60042, 13GSZD60043, 13GSZD60045, 13GSZD60046, 13GSZD60048, 13HSZD60004, 13HSZD60005, 13HSZD60006, 13HSZD60007, 13HSZD60009, 13HSZD60010, 13HSZD60011, 13HSZD60013, 13HSZD60014, 13HSZD60015, 13HSZD60017, 13JSZD60002, 13JSZD60004, 13JSZD60010, 13JSZD60011, 13JSZD60013, 13JSZD60014, 13JSZD60015, 13JSZD60017, 13JSZD60018, 13JSZD60019, 13JSZD60020, 13JSZD60021, 13JSZD60023, 13JSZD60026, 13JSZD60034, 13JSZD60035, 13JSZD60037, 13JSZD60038, 13JSZD60039, 13JSZD60040, 13JSZD60041, 13JSZD60043, 13JSZD60045, 13JSZD60046, 13JSZD60047, 13JSZD60048, 13JSZD60049, 13JSZD60050, 13JSZD60051, 13JSZD60052, 13JSZD60053, 13JSZD60054, 13JSZD60055, 13JSZD60058, 13JSZD60060, 13JSZD60061, 13JSZD60063, 13JSZD60064, 13JSZD60065, 13JSZD60067, 13JSZD60069, 13JSZD60071, 13JSZD60074, 13JSZD60076, 13JSZD60077, 13JSZD60078, 13JSZD60079, 13JSZD60080, 14ESZD60005, 14ESZD60007, 14ESZD60008, 14ESZD60015, 14ESZD60016, 14ESZD60020, 14ESZD60021, 14ESZD60023, 14ESZD60024, 14ESZD60025, 14ESZD60038, 14ESZD60039, 14ESZD60044,14ESZD60057, 14ESZD60058, 14ESZD60061, 14ESZD60062, 14ESZD60063, 14ESZD60067, 14ESZD60069, 14ESZD60070, 14ESZD60071, 14ESZD60075, 14ESZD60076, 14ESZD60078, 14ESZD60080, 14ESZD60082, 14ESZD60087, 14ESZD60089, 14ESZD60090, 14ESZD60092, 14ESZD60093, 14ESZD60094, 14ESZD60096, 14ESZD60101, 14ESZD60103, 14ESZD60104, 14ESZD60105, 14ESZD60106, 14ESZD60108, 14ESZD60109, 14ESZD60111, 14ESZD60112, 14ESZD60113 & 14ESZD60114. Model #AIRPTMBDY20, Serial #s: 12KSZD60009, 12KSZD60025, 12KSZD60084, 12KSZD60097, 12KSZD60104, 12KSZD60132, 12KSZD60135, 12KSZD60150, 12LSZD60016, 12LSZD60045, 12LSZD60061, 12LSZD60065, 12LSZD60082, 12LSZD60087, 12LSZD60111, 12LSZD60119, 12LSZD60143, 12LSZD60148, 12LSZD60153, 13CSZD60021, 13CSZD60049, 13CSZD60060, 13CSZD60106, 13CSZD60111, 13CSZD60123, 13CSZD60129, 13CSZD60142, 13CSZD60158, 13CSZD60192, 13CSZD60202, 13CSZD60210, 13DSZD60004, 13DSZD60006, 13DSZD60011, 13DSZD60022, 13DSZD60038, 13DSZD60050, 13DSZD60051, 13DSZD60052, 13DSZD60054, 13ESZD60001, 13ESZD60013, 13ESZD60026, 13FSZD60007, 13FSZD60026, 13FSZD60029, 13FSZD60077, 13FSZD60091, 13FSZD60092, 13FSZD60095, 13FSZD60099, 13GSZD60029, 13GSZD60044, 13HSZD60012, 13HSZD60016, 13JSZD60024, 13JSZD60033, 13JSZD60044, 13JSZD60056, 13JSZD60066, 14ESZD60017, 14ESZD60018, 14ESZD60027, 14ESZD60037, 14ESZD60040, 14ESZD60077, 14ESZD60081, 14ESZD60083 & 14ESZD60084. Model #AIRPTBASE, Serial #s: 12KSZD60068, 12KSZD60119, 12LSZD60106, 12LSZD60166, 12LSZD60180, 13CSZD60092, 13DSZD60063, 13DSZD60064, 13DSZD60090, 13FSZD60008, 13FSZD60028, 13FSZD60046, 13FSZD60047, 13HSZD60001, 13JSZD60001, 13JSZD60068, 14ESZD60014, 14ESZD60022, 14ESZD60065, 14ESZD60068, 14ESZD60072, 14ESZD60074, 14ESZD60086, 14ESZD60088, 14ESZD60091, 14ESZD60097, 14ESZD60098, 14ESZD60102 & 14ESZD60107.
Quantity recalled1,057 finished devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2358-2015
FDA event ID
71613
Recalling firm
Invacare, Elyria, OH
Classification
Class II
Status
Terminated
Recall initiated
2 Feb 2015
FDA classified
10 Aug 2015
Reported
19 Aug 2015
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Packaging Defects

Timeline

2 Feb 2015Recall initiated by company
10 Aug 2015Classified by FDA+189 days
19 Aug 2015Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The batteries used in the Invacare¿ Pronto¿ Air Personal Transporter models power wheelchairs have the possibility to overheat during charging which could potentially result in leaking battery acid and/or swelling battery, loss of use, chemical burns and/or property damage.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.

Where it was distributed

Worldwide Distribution - US (nationwide) Distribution including Puerto Rico, and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA and WI., and to the countries of : AUSTRALIA, CANDA, FRANCE, NEW ZEALAND, SOUTH AFRICA, TRINIDAD AND TOBAGO

Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland

Questions about this recall

Why was it recalled?

The batteries used in the Invacare¿ Pronto¿ Air Personal Transporter models power wheelchairs have the possibility to overheat during charging which could potentially result in leaking battery acid and/or swelling battery, loss of use, chemical burns and/or property damage.

Which lots are affected?

Model #AIRPTMBDY18, Serial #s: 12JSZD60025, 12JSZD60026, 12JSZD60027, 12KSZD60001, 12KSZD60002, 12KSZD60004, 12KSZD60005, 12KSZD60006, 12KSZD60007, 12KSZD60008, 12KSZD60010, 12KSZD60013, 12KSZD60014, 12KSZD60015, 12KSZD60016, 12KSZD60017, 12KSZD60018, 12KSZD60019, 12KSZD60020, 12KSZD60021, 12KSZD60022, 12KSZD60023, 12KSZD60024, 12KSZD60026, 12KSZD60028, 12KSZD60029, 12KSZD60030, 12KSZD60031, 12KSZD60032, 12KSZD60033, 12KSZD60034, 12KSZD60035, 12KSZD60036, 12KSZD60037, 12KSZD60038, 12KSZD60039, 12KSZD60040, 12KSZD60041, 12KSZD60042, 12KSZD60043, 12KSZD60045, 12KSZD60046, 12KSZD60047, 12KSZD60048, 12KSZD60049, 12KSZD60050, 12KSZD60051, 12KSZD60052, 12KSZD60053, 12KSZD60054, 12KSZD60055, 12KSZD60056, 12KSZD60057, 12KSZD60058, 12KSZD60059, 12KSZD60060, 12KSZD60061, 12KSZD60063, 12KSZD60064, 12KSZD60065, 12KSZD60066, 12KSZD60067, 12KSZD60069, 12KSZD60070, 12KSZD60071, 12KSZD60072, 12KSZD60073, 12KSZD60075, 12KSZD60076, 12KSZD60077, 12KSZD60078, 12KSZD60079, 12KSZD60080, 12KSZD60081, 12KSZD60082, 12KSZD60083, 12KSZD60085, 12KSZD60086, 12KSZD60087, 12KSZD60088, 12KSZD60091, 12KSZD60092, 12KSZD60093, 12KSZD60094, 12KSZD60095, 12KSZD60096, 12KSZD60098, 12KSZD60099, 12KSZD60100, 12KSZD60101, 12KSZD60103, 12KSZD60105, 12KSZD60107, 12KSZD60108, 12KSZD60109, 12KSZD60110, 12KSZD60111, 12KSZD60112, 12KSZD60114, 12KSZD60115, 12KSZD60116, 12KSZD60117, 12KSZD60118, 12KSZD60120, 12KSZD60121, 12KSZD60122, 12KSZD60123, 12KSZD60124, 12KSZD60125, 12KSZD60126, 12KSZD60127, 12KSZD60128, 12KSZD60129, 12KSZD60130, 12KSZD60131, 12KSZD60134, 12KSZD60136, 12KSZD60137, 12KSZD60138, 12KSZD60139, 12KSZD60140, 12KSZD60141, 12KSZD60142, 12KSZD60143, 12KSZD60144, 12KSZD60145, 12KSZD60146, 12KSZD60147, 12KSZD60148, 12KSZD60149, 12KSZD60151, 12KSZD60152, 12KSZD60153, 12KSZD60154, 12KSZD60155, 12KSZD60156, 12KSZD60158, 12KSZD60159, 12KSZD60160, 12KSZD60162, 12KSZD60163, 12KSZD60164, 12KSZD60165, 12KSZD60166, 12KSZD60168, 12KSZD60169, 12KSZD60170, 12KSZD60171, 12KSZD60172, 12KSZD60173, 12KSZD60174, 12KSZD60176, 12KSZD60177, 12KSZD60178, 12KSZD60179, 12KSZD60180, 12KSZD60181, 12KSZD60182, 12KSZD60183, 12KSZD60186, 12KSZD60187, 12KSZD60188, 12KSZD60189, 12KSZD60190, 12KSZD60191, 12KSZD60192, 12KSZD60193, 12KSZD60194, 12KSZD60195, 12KSZD60197, 12KSZD60198, 12KSZD60199, 12KSZD60200, 12KSZD60201, 12KSZD60203, 12KSZD60204, 12KSZD60205, 12KSZD60206, 12KSZD60207, 12KSZD60209, 12KSZD60211, 12KSZD60212, 12KSZD60213, 12KSZD60214, 12KSZD60215, 12KSZD60216, 12KSZD60217, 12KSZD60219, 12KSZD60220, 12LSZD60001, 12LSZD60002, 12LSZD60003, 12LSZD60004, 12LSZD60006, 12LSZD60007, 12LSZD60008, 12LSZD60009, 12LSZD60011, 12LSZD60012, 12LSZD60014, 12LSZD60015, 12LSZD60017, 12LSZD60018, 12LSZD60020, 12LSZD60021, 12LSZD60024, 12LSZD60025, 12LSZD60026, 12LSZD60027, 12LSZD60028, 12LSZD60029, 12LSZD60030, 12LSZD60031, 12LSZD60032, 12LSZD60033, 12LSZD60034, 12LSZD60035, 12LSZD60036, 12LSZD60037, 12LSZD60040, 12LSZD60042, 12LSZD60043,12LSZD60044, 12LSZD60046, 12LSZD60047, 12LSZD60048, 12LSZD60049, 12LSZD60050, 12LSZD60051, 12LSZD60052, 12LSZD60053, 12LSZD60054,12LSZD60055, 12LSZD60056, 12LSZD60058, 12LSZD60059, 12LSZD60063, 12LSZD60064, 12LSZD60067, 12LSZD60068, 12LSZD60069, 12LSZD60070, 12LSZD60071, 12LSZD60072, 12LSZD60073, 12LSZD60074, 12LSZD60075, 12LSZD60076, 12LSZD60077, 12LSZD60078, 12LSZD60079, 12LSZD60080, 12LSZD60081, 12LSZD60083, 12LSZD60084, 12LSZD60085, 12LSZD60086, 12LSZD60088, 12LSZD60089, 12LSZD60091, 12LSZD60093, 12LSZD60094, 12LSZD60095, 12LSZD60096, 12LSZD60097, 12LSZD60098, 12LSZD60099, 12LSZD60100, 12LSZD60101, 12LSZD60102, 12LSZD60103, 12LSZD60104, 12LSZD60105, 12LSZD60107, 12LSZD60109, 12LSZD60110, 12LSZD60112, 12LSZD60113, 12LSZD60114, 12LSZD60115, 12LSZD60116, 12LSZD60117, 12LSZD60121, 12LSZD60122, 12LSZD60123, 12LSZD60124, 12LSZD60126, 12LSZD60127, 12LSZD60128, 12LSZD60129, 12LSZD60130, 12LSZD60131, 12LSZD60132, 12LSZD60134, 12LSZD60135, 12LSZD60136, 12LSZD60137, 12LSZD60139, 12LSZD60140, 12LSZD60141, 12LSZD60142, 12LSZD60144, 12LSZD60145, 12LSZD60146, 12LSZD60147, 12LSZD60149, 12LSZD60150, 12LSZD60151, 12LSZD60152, 12LSZD60155, 12LSZD60156, 12LSZD60158, 12LSZD60159, 12LSZD60160, 12LSZD60161, 12LSZD60162, 12LSZD60163, 12LSZD60164, 12LSZD60167, 12LSZD60168, 12LSZD60169, 12LSZD60170, 12LSZD60171, 12LSZD60172, 12LSZD60173, 12LSZD60174, 12LSZD60175, 12LSZD60176, 12LSZD60177, 12LSZD60178, 12LSZD60181, 12LSZD60182, 12LSZD60185, 12LSZD60187, 12LSZD60190, 12LSZD60192, 12LSZD60193, 12LSZD60194, 12LSZD60195, 12LSZD60197, 12LSZD60198, 12LSZD60199, 12LSZD60200, 12LSZD60201, 12LSZD60202, 12LSZD60203, 12LSZD60205, 12LSZD60206, 12LSZD60207, 12LSZD60208, 12LSZD60209, 12LSZD60210, 12LSZD60211, 12LSZD60212, 12LSZD60213, 12LSZD60214, 12LSZD60215, 12LSZD60216, 13CSZD60001, 13CSZD60002, 13CSZD60003, 13CSZD60004, 13CSZD60005, 13CSZD60006, 13CSZD60008, 13CSZD60009, 13CSZD60011, 13CSZD60013, 13CSZD60015, 13CSZD60016, 13CSZD60018, 13CSZD60019, 13CSZD60022, 13CSZD60023, 13CSZD60024, 13CSZD60025, 13CSZD60026, 13CSZD60028, 13CSZD60029, 13CSZD60031, 13CSZD60032, 13CSZD60034, 13CSZD60035, 13CSZD60036, 13CSZD60037, 13CSZD60039, 13CSZD60040, 13CSZD60041, 13CSZD60042, 13CSZD60044, 13CSZD60045, 13CSZD60046, 13CSZD60047, 13CSZD60048, 13CSZD60050, 13CSZD60051, 13CSZD60052, 13CSZD60054, 13CSZD60055, 13CSZD60056, 13CSZD60057, 13CSZD60058, 13CSZD60059, 13CSZD60066, 13CSZD60071, 13CSZD60072, 13CSZD60074, 13CSZD60075, 13CSZD60076, 13CSZD60077, 13CSZD60078, 13CSZD60079, 13CSZD60080, 13CSZD60082, 13CSZD60083, 13CSZD60084, 13CSZD60085, 13CSZD60087, 13CSZD60088, 13CSZD60091, 13CSZD60093, 13CSZD60095, 13CSZD60097, 13CSZD60098, 13CSZD60099, 13CSZD60100, 13CSZD60101, 13CSZD60102, 13CSZD60103, 13CSZD60104, 13CSZD60105, 13CSZD60107, 13CSZD60108, 13CSZD60110, 13CSZD60112, 13CSZD60113, 13CSZD60114, 13CSZD60115, 13CSZD60116, 13CSZD60117, 13CSZD60118, 13CSZD60119, 13CSZD60128, 13CSZD60130, 13CSZD60131, 13CSZD60133, 13CSZD60134, 13CSZD60135, 13CSZD60136, 13CSZD60138, 13CSZD60140, 13CSZD60141, 13CSZD60144, 13CSZD60146, 13CSZD60147, 13CSZD60148, 13CSZD60149, 13CSZD60150, 13CSZD60151, 13CSZD60153, 13CSZD60154, 13CSZD60155, 13CSZD60156, 13CSZD60157, 13CSZD60159, 13CSZD60163, 13CSZD60164, 13CSZD60166, 13CSZD60167, 13CSZD60168, 13CSZD60170, 13CSZD60171, 13CSZD60173, 13CSZD60175, 13CSZD60178, 13CSZD60180, 13CSZD60182, 13CSZD60183, 13CSZD60188, 13CSZD60189, 13CSZD60191, 13CSZD60193, 13CSZD60194, 13CSZD60198. 13CSZD60199, 13CSZD60200, 13CSZD60201, 13CSZD60203, 13CSZD60204, 13CSZD60205, 13CSZD60207, 13CSZD60208, 13CSZD60211, 13CSZD60213, 13CSZD60214, 13CSZD60215, 13CSZD60216, 13CSZD60219, 13CSZD60224, 13CSZD60225, 13CSZD60227, 13CSZD60229, 13DSZD60001, 13DSZD60002, 13DSZD60003, 13DSZD60004, 13DSZD60005, 13DSZD60007, 13DSZD60008, 13DSZD60010, 13DSZD60012, 13DSZD60013, 13DSZD60015, 13DSZD60016, 13DSZD60017, 13DSZD60019, 13DSZD60020, 13DSZD60021, 13DSZD60023, 13DSZD60024, 13DSZD60026, 13DSZD60027, 13DSZD60029, 13DSZD60030, 13DSZD60032, 13DSZD60033, 13DSZD60034, 13DSZD60035, 13DSZD60036, 13DSZD60037, 13DSZD60039, 13DSZD60040, 13DSZD60041, 13DSZD60042, 13DSZD60043, 13DSZD60044, 13DSZD60045, 13DSZD60046, 13DSZD60047, 13DSZD60055, 13DSZD60056, 13DSZD60057, 13DSZD60058, 13DSZD60059, 13DSZD60060, 13DSZD60061, 13DSZD60062, 13DSZD60065, 13DSZD60066, 13DSZD60067, 13DSZD60068, 13DSZD60069, 13DSZD60074, 13DSZD60075, 13DSZD60076, 13DSZD60077, 13DSZD60078, 13DSZD60079, 13DSZD60080, 13DSZD60081, 13DSZD60082, 13DSZD60084, 13DSZD60085, 13DSZD60086, 13DSZD60087, 13DSZD60088, 13DSZD60089, 13DSZD60091, 13DSZD60092, 13DSZD60095, 13DSZD60096, 13DSZD60097, 13DSZD60098, 13DSZD60099, 13DSZD60100, 13DSZD60101, 13DSZD60102, 13DSZD60103, 13DSZD60104, 13DSZD60105, 13DSZD60107, 13DSZD60108, 13DSZD60109, 13DSZD60110, 13ESZD60002, 13ESZD60003, 13ESZD60004, 13ESZD60005, 13ESZD60007, 13ESZD60008, 13ESZD60009, 13ESZD60010, 13ESZD60011l, 13ESZD60012, 13ESZD60014, 13ESZD60015, 13ESZD60016, 13ESZD60017, 13ESZD60018, 13ESZD60019, 13ESZD60020, 13ESZD60021, 13ESZD60022, 13ESZD60023, 13ESZD60024, 13ESZD60025, 13ESZD60027, 13ESZD60030, 13ESZD60031, 13ESZD60032, 13ESZD60033, 13ESZD60034, 13ESZD60035, 13ESZD60036, 13ESZD60037, 13ESZD60038, 13ESZD60039, 13ESZD60040, 13ESZD60041, 13FSZD60001, 13FSZD60002, 13FSZD60003, 13FSZD60004, 13FSZD60005, 13FSZD60006, 13FSZD60009, 13FSZD60011, 13FSZD60012, 13FSZD60013, 13FSZD60014, 13FSZD60015, 13FSZD60016, 13FSZD60017, 13FSZD60018, 13FSZD60019, 13FSZD60020, 13FSZD60021, 13FSZD60022, 13FSZD60023, 13FSZD60024, 13FSZD60025, 13FSZD60027, 13FSZD60030, 13FSZD60031, 13FSZD60032, 13FSZD60033, 13FSZD60034, 13FSZD60035, 13FSZD60036, 13FSZD60037, 13FSZD60040, 13FSZD60041, 13FSZD60042, 13FSZD60043, 13FSZD60044, 13FSZD60045, 13FSZD60048, 13FSZD60049, 13FSZD60050, 13FSZD60051, 13FSZD60052, 13FSZD60053,13FSZD60054, 13FSZD60055, 13FSZD60056, 13FSZD60057, 13FSZD60058, 13FSZD60060, 13FSZD60061, 13FSZD60062, 13FSZD60063, 13FSZD60064, 13FSZD60067, 13FSZD60068, 13FSZD60069, 13FSZD60070, 13FSZD60071, 13FSZD60072, 13FSZD60075, 13FSZD60076, 13FSZD60078, 13FSZD60079, 13FSZD60080, 13FSZD60081, 13FSZD60082, 13FSZD60084, 13FSZD60085, 13FSZD60086, 13FSZD60088, 13FSZD60089, 13FSZD60094, 13FSZD60096, 13FSZD60097, 13FSZD60098, 13FSZD60100, 13FSZD60101, 13FSZD60102,13FSZD60103, 13FSZD60104, 13FSZD60106, 13FSZD60107, 13FSZD60111, 13FSZD60112, 13FSZD60114, 13FSZD60115, 13FSZD60118, 13FSZD60119, 13FSZD60120, 13FSZD60121, 13GSZD60001, 13GSZD60003, 13GSZD60004, 13GSZD60006, 13GSZD60007, 13GSZD60010, 13GSZD60011, 13GSZD60013, 13GSZD60014, 13GSZD60015, 13GSZD60016, 13GSZD60017, 13GSZD60018, 13GSZD60019, 13GSZD60022, 13GSZD60023, 13GSZD60024, 13GSZD60025, 13GSZD60026, 13GSZD60027, 13GSZD60030, 13GSZD60031, 13GSZD60032, 13GSZD60033, 13GSZD60036, 13GSZD60037, 13GSZD60038, 13GSZD60040, 13GSZD60042, 13GSZD60043, 13GSZD60045, 13GSZD60046, 13GSZD60048, 13HSZD60004, 13HSZD60005, 13HSZD60006, 13HSZD60007, 13HSZD60009, 13HSZD60010, 13HSZD60011, 13HSZD60013, 13HSZD60014, 13HSZD60015, 13HSZD60017, 13JSZD60002, 13JSZD60004, 13JSZD60010, 13JSZD60011, 13JSZD60013, 13JSZD60014, 13JSZD60015, 13JSZD60017, 13JSZD60018, 13JSZD60019, 13JSZD60020, 13JSZD60021, 13JSZD60023, 13JSZD60026, 13JSZD60034, 13JSZD60035, 13JSZD60037, 13JSZD60038, 13JSZD60039, 13JSZD60040, 13JSZD60041, 13JSZD60043, 13JSZD60045, 13JSZD60046, 13JSZD60047, 13JSZD60048, 13JSZD60049, 13JSZD60050, 13JSZD60051, 13JSZD60052, 13JSZD60053, 13JSZD60054, 13JSZD60055, 13JSZD60058, 13JSZD60060, 13JSZD60061, 13JSZD60063, 13JSZD60064, 13JSZD60065, 13JSZD60067, 13JSZD60069, 13JSZD60071, 13JSZD60074, 13JSZD60076, 13JSZD60077, 13JSZD60078, 13JSZD60079, 13JSZD60080, 14ESZD60005, 14ESZD60007, 14ESZD60008, 14ESZD60015, 14ESZD60016, 14ESZD60020, 14ESZD60021, 14ESZD60023, 14ESZD60024, 14ESZD60025, 14ESZD60038, 14ESZD60039, 14ESZD60044,14ESZD60057, 14ESZD60058, 14ESZD60061, 14ESZD60062, 14ESZD60063, 14ESZD60067, 14ESZD60069, 14ESZD60070, 14ESZD60071, 14ESZD60075, 14ESZD60076, 14ESZD60078, 14ESZD60080, 14ESZD60082, 14ESZD60087, 14ESZD60089, 14ESZD60090, 14ESZD60092, 14ESZD60093, 14ESZD60094, 14ESZD60096, 14ESZD60101, 14ESZD60103, 14ESZD60104, 14ESZD60105, 14ESZD60106, 14ESZD60108, 14ESZD60109, 14ESZD60111, 14ESZD60112, 14ESZD60113 & 14ESZD60114. Model #AIRPTMBDY20, Serial #s: 12KSZD60009, 12KSZD60025, 12KSZD60084, 12KSZD60097, 12KSZD60104, 12KSZD60132, 12KSZD60135, 12KSZD60150, 12LSZD60016, 12LSZD60045, 12LSZD60061, 12LSZD60065, 12LSZD60082, 12LSZD60087, 12LSZD60111, 12LSZD60119, 12LSZD60143, 12LSZD60148, 12LSZD60153, 13CSZD60021, 13CSZD60049, 13CSZD60060, 13CSZD60106, 13CSZD60111, 13CSZD60123, 13CSZD60129, 13CSZD60142, 13CSZD60158, 13CSZD60192, 13CSZD60202, 13CSZD60210, 13DSZD60004, 13DSZD60006, 13DSZD60011, 13DSZD60022, 13DSZD60038, 13DSZD60050, 13DSZD60051, 13DSZD60052, 13DSZD60054, 13ESZD60001, 13ESZD60013, 13ESZD60026, 13FSZD60007, 13FSZD60026, 13FSZD60029, 13FSZD60077, 13FSZD60091, 13FSZD60092, 13FSZD60095, 13FSZD60099, 13GSZD60029, 13GSZD60044, 13HSZD60012, 13HSZD60016, 13JSZD60024, 13JSZD60033, 13JSZD60044, 13JSZD60056, 13JSZD60066, 14ESZD60017, 14ESZD60018, 14ESZD60027, 14ESZD60037, 14ESZD60040, 14ESZD60077, 14ESZD60081, 14ESZD60083 & 14ESZD60084. Model #AIRPTBASE, Serial #s: 12KSZD60068, 12KSZD60119, 12LSZD60106, 12LSZD60166, 12LSZD60180, 13CSZD60092, 13DSZD60063, 13DSZD60064, 13DSZD60090, 13FSZD60008, 13FSZD60028, 13FSZD60046, 13FSZD60047, 13HSZD60001, 13JSZD60001, 13JSZD60068, 14ESZD60014, 14ESZD60022, 14ESZD60065, 14ESZD60068, 14ESZD60072, 14ESZD60074, 14ESZD60086, 14ESZD60088, 14ESZD60091, 14ESZD60097, 14ESZD60098, 14ESZD60102 & 14ESZD60107.

Where was it sold?

Worldwide Distribution - US (nationwide) Distribution including Puerto Rico, and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA and WI., and to the countries of : AUSTRALIA, CANDA, FRANCE, NEW ZEALAND, SOUTH AFRICA, TRINIDAD AND TOBAGO

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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