Equator Forced Air Convective Warming System, Reference Number EQ 5000
This recall has been terminated (originally issued February 3, 2005).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- December 15, 2004
- Posted
- February 3, 2005
- Terminated
- June 27, 2006
- Recall Number
- Z-0497-05
- Quantity
- 206 units
- Firm Location
- Rockland, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Warmer heater coil may come in contact with the filter housing, causing a small area of the plastic housing to melt
Distribution
Nationwide Foreign: Nederland BV, UK, Finland
Lot / Code Info
Serial No. 2004126, 10040116, 20020088, 20020125, 20030104, 20030105, 20030133, 20030141, 20030146, 20030194, 20030199, 20030254, 20030287, 20030312, 20030394, 20030401, 20030408, 20030428, 20030460, 20030512, 20030522, 20030535, 20030627, 20030665, 20030759, 20030791, 20030818, 20030960, 20031030, 20031034, 20031039, 20031049, 20031056, 20031105, 20031151, 20031164, 20031172, 20031271, 20031336, 20031414, 20031417, 20031418, 20031423, 20031444, 20031488, 20031550, 20031622, 20031632, 20031661, 20031669, 20031681, 20040007, 20040010, 20040014, 20040021, 20040104, 20040106, 20040115, 20040124, 20040127, 20040153, 20040162, 20040164, 20040166, 20040202, 20040203, 20040208, 20040227, 20040290, 20040377, 20040378, 20040379, 20040380, 20040381, 20040382, 20040383, 20040385, 20040386, 20040387, 20040388, 20040389, 20040391, 20040392, 20040393, 20040394, 20040395, 20040396, 20040397, 20040398, 20040399, 20040400, 20040401, 20040402, 20040406, 20040408, 20040409, 20040410, 20040412, 20040414, 20040415, 20040416, 20040419, 20040420, 20040422, 20040427, 20040429, 20040505, 20040715, 20040817, 20040996, 20041156, 20041157, 20041158, 20041159, 20041160, 20041161, 20041162, 20041163, 20041164, 20041165, 20041166, 20041167, 20041168, 20041169, 20041170, 20041171, 20041172, 20041173, 20041174, 20041175, 20041176, 20041177, 20041178, 20041179, 20041180, 20041181, 20041182, 20041183, 20041184, 20041185, 20041186, 20041187, 20041188, 20041189, 20041190, 20041191, 20041192, 20041193, 20041194, 20041195, 20041196, 20041197, 20041198, 20041199, 20041200, 20041201, 20041202, 20041203, 20041204, 20041205, 20041206, 20041207, 20041208, 20041209, 20041210, 20041211, 20041212, 20041213, 20041214, 20041215, 20041216, 20041217, 20041218, 20041219, 20041220, 20041221, 20041222, 20041223, 20041224, 20041225, 20041227, 20041228, 20041229, 20041230, 20041231, 20041232, 20041233, 20041234, 20041235, 20041236, 20041237, 20041238, 20041239, 20041240, 20041241, 20041242, 20041244, 20041245, 20041246, 20041247, 20041249, 20041250, 20041251, 20041253, 20041256, 20041257, 20041258, 20041259, 20041260, 20041261, 20041262, 20041263, 20041264, 20041265, 20041266, 20041267, 20041268, 20041269, 20041270, 20041271, 20041272, 20041273, 20041274, 20041275, 20041276, 20041277, 20041278, 20041279, 20041280, 20041281, 20041282, 20041283, 20041284, 20041285, 20041286, 20041287, 20041288, 20041289, 20041290, 20041291, 20041293, 20041294, 20041295, 20041296, 20041297, 20041298, 20041299, 20041300, 20041301, 20041302, 20041303, 20041304, 20041305, 20041306, 20041307, 20041308, 20041309, 20041310, 20041311, 20041312, 20041313, 20041314, 20041315, 20041316, 20041317, 20041318, 20041319, 20041320, 20041321, 20041322, 20041323, 20041324, 20041325, 20041326, 20041327, 20041364, 20041581, 29941255
Root Cause
Other
Action Taken
Smiths Medical ASD notified customers by letter issued Fed''X on 12/15/04. Accounts are requested not to use the device and return the unit if the the unit has not yet been placed into service. If the unit has been placed into service and operated for more than one hour then the problem will not occur. EQ-5000 unit(s) will be replaced.