Class 3 Device Recall

• Date Initiated by Firm: December 15, 2004
• Date Posted: February 03, 2005
• Recall Status: Terminated on June 27, 2006
• Recall Number: Z-0497-05
• Recall Event ID: 30703
• 510(K)Number: K011907
• Product Classification: System, Thermal Regulating - Product Code DWJ
• Product: Equator Forced Air Convective Warming System, Reference Number EQ 5000
• Code Information: 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
• FEI Number: 1221261
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 160 Weymouth St; Rockland MA 02370-1136
• For Additional Information Contact: Shirley Duggan; 781-878-8011 Ext. 7835
• Manufacturer Reason for Recall: Warmer heater coil may come in contact with the filter housing, causing a small area of the plastic housing to melt
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 206 units
• Distribution: Nationwide Foreign: Nederland BV, UK, Finland
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DWJ