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U.S. Department of Health and Human Services

Class 2 Device Recall CDI 500 Monitor

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  Class 2 Device Recall CDI 500 Monitor see related information
Date Initiated by Firm February 03, 2012
Date Posted April 06, 2012
Recall Status1 Terminated 3 on August 29, 2013
Recall Number Z-1379-2012
Recall Event ID 60152
510(K)Number K972962  
Product Classification Monitor, blood-gas, on-line, cardiopulmonary bypass - Product Code DRY
Product CDI Blood Parameter Monitoring System 500, 500AHCT.

Intended for use during cardiopulmonary bypass procedures.
Code Information 500AHCT CDI Blood Parameter Monitoring TBD System 500 with Arterial blood parameter module and Hematocrit/ Saturation probe: 1023, 1025-1027, 1029-1031, 1034, 1035, 1037, 1040, 1045, 1048, 1054-1058, 1060-1062, 1064, 1065, 1072-1074, 1076-1095, 1098-1100, 1102, 1106-1110, 1114, 1116-1129, 1131, 1132, 1141-1145, 1153-1165, 1169-1180, 1186-1191, 1194-1210, 1212-1215, 1221-1230, 1236-1243, 1249-1253, 1256-1260, 1265-1269, 1275-1284, 1290-1294, 1300-1303, 1310, 1311, 1316-1320, 1322-1331, 1335-1339, 1345-1349, 1359-1378, 1384-1388, 1394-1398, 1409-1413, 1419, 1434-1438, 1444-1448, 1454-1458, 1469-1478, 1481, 1482, 1484-1493, 1495-1503, 1505-1520, 1528, 1531-1553, 1555-1558, 1567-1596, 1607-1616, 1632-1636, 1647-1656, 1667-1671, 1677-1681, 1687-1696, 1702-1711, 1717-1721, 1728-1732, 1738-1753, 1759-1775, 1777-1786, 1790-1794, 1796-1804,1810-1814, 1820-1829, 1831-1843, 1847-1850, 1856, 1861-1885, 1891-1900, 1906-1915, 1921-1925, 1931-1935, 1941-1950, 1975, 1986-2015, 2017-2022, 2024-2027, 2039, 2041-2044, 2046-2058, 2064, 2068, 2069, 2078-2085, 2087-2096, 2108, 2116, 2118-2122, 2132-2137, 2143- 2148, 2156-2176, 2183, 2184, 2188, 2191-2194, 2200-2213, 2215, 2220-2223, 2225-2227, 2232-2242, 2247, 2248, 2254, 2259, 2261, 2262, 2264, 2269-2272, 2278, 2280-2284, 2292-2294, 2299-2312, 2330-2337, 2353, 2359-2363, 2376, 2378-2388, 2398-2402, 2409-2416, 2427-2431, 2437, 2438, 2445-2452, 2459-2462, 2468, 2469, 2473-2475, 2484-2486, 2505-2513, 2518-2520, 2526-2540, 2557-2564, 2583-2586, 2604-2628, 2643-2645, 2648-2655, 2657-2660, 2663, 2681-2688, 2692-2694, 2697-2699, 2709, 2717-2721, 2728-2736, 2738-2741, 2748-2756, 2774-2782, 2785-2787, 2789-2792, 2796-2799, 2803, 2809-2814, 2821-2836, 2840-2845, 2850-2859, 2861-2864, 2871-2879, 2896-2900, 2903-2905, 2909-2912, 2916-2919, 2922, 2923, 2927-2936, 2941, 2948-2951, 2953-2957, 2976-2978, 2984-2989, 3000-3007, 3014-3021, 3028-3039, 3042-3051, 3056-3072, 3076-3082, 3088-3095, 3097-3114, 3117-3124, 3126-3130, 3136-3138, 3147-3151, 3154, 3163-3168, 3183-3189, 3197-3213, 3221-3224, 3229-3231, 3233-3237, 3246, 3247, 3250-3260, 3269-3286, 3290, 3307-3313, 3324-3328, 3335-3339, 3350-3353, 3358-3368, 3374-3382, 3392, 3393, 3398-3401, 3407-3409, 3411-3415, 3428-3433, 3438-3440, 3448, 3457, 3463-3468, 3473-3479, 3483-3488, 3491-3499, 3504-3508, 3511-3517, 3519-3533, 3536-3540, 3546-3570, 3574-3589, 3610, 3611, 3620-3623, 3632-3635, 3640-3642, 3649-3660, 3662-3668, 3682-3697, 3704-3714, 3717-3721, 3727-3737, 3745-3752, 3758-3768, 3781-3783, 3788-3798, 3805-3810, 3817-3826, 3831-3837, 3842-3851, 3882-3891, 3900, 3901, 3907-3911, 3922, 3923, 3932-3936, 3953-3961, 3966-3970, 3975-3985, 3990-3994, 3999-4005, 4030-4037, 4044-4049, 4056-4069, 4076-4081, 4090-4095, 4100-4104, 4109-4113, 4133-4142, 4149-4168, 4186-4202, 4213-4218, 4225-4229, 4242-4259, 4281-4289, 4300-4306, 4311-4317, 4324-4334, 4345-4350, 4353-4371, 5011-5035, 5040-5047, 5057-5064, 5078-5081, 5086-5093, 5102-5117, 5126-5141, 5150-5157, 5170-5177, 5180-5189, 5191-5196, 5199-5209, 5214-5221, 5226-5237, 5246-5249, 5254-5273, 5278-5281, 5286-5289, 5294-5297, 5306-5317, 5322-5329, 5345-5348, 5350-5353, 5358-5369, 5375-5382, 5387, 5388, 5500-5515, 5527-5531, 5542-5556, 5562-5564, 5566, 5569, 5571, 5572, 5574-5577, 5581-5583, and 5593-5600.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
734-741-6173
Manufacturer Reason
for Recall		 Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life.
FDA Determined
Cause 2		 Labeling design
Action On 2/3/12 all consignees received an URGENT MEDICAL DEVICE RECALL letter via Federal Express. The letter described the reason for the recall, identified the affected product population, what to do in the event of a failure, the potential hazard, and correction. Terumo CVS will update the Operator's Manual for the CDI 500 with instructions to replace the battery within its useful life. Users are to review the notice and ensure that all users are made aware of the issue. In addition, the Customer Response Form should be completed and returned. Users can contact their local Terumo Cardiovascular Systems representative or call 1-800-521-2818 with questions or concerns, to check the last time system batteries were replaced, or to schedule maintenance for systems approaching 10 years.
Quantity in Commerce 3,829 units
Distribution Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CA, CO, CT, DC, DE, 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, PR, SC, SD, TN, TX, UT, WV, WA, and WI and the countries of Japan, Germany, Barbados, Saudi Arabia, Columbia, Uruguay, Ecuador, Trinidad, Costa Rica, Paraguay, Panama, Belgium, Jordan, Libya, Mexico, Brazil, Honduras, Canada, Korea, Dominica Republic, El Salvador, Guatemala, Vietnam, Chile, Hong Kong, United Arab Emirates, Singapore, Australia, Malaysia, Taiwan, Philippines, Mexico, Thailand, Vietnam, and South Africa.
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 = DRY and Original Applicant = 3M COMPANY
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