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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Detail

Product Description CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
Recall Number Z-1731-2013
Classification Class II
Code Info Catalog number: 500AHCT* and serial numbers: 1023,1025-1027,1029-1031, 1034,1035,1037,1040, 1045, 1048, 1054-1058, 1060-1062, 1064, 1065, 1072-1074, 1076-1095,1098-1100,1106-1110,1114,1116-1129,1131,1132,1141-1145, 1153-1165,1169-1180,1186-1191,1194-1210, 1212-1215,1221, 1230, 1237-1243,1249-1253,1256-1260,1265-1269,1275-1284,1290-1294,1300-1303, 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, 2024-2028, 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, 2684-2688,2692-2694,2697-2699, 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, 5542-5556,5562-5564,5566-5577,5581-5583, 5593-5600, 5609-5660, 5662-5680, 5682-5688, 5690-5706, 5708-5713, 5715-5722, 5725-5727,and 5731.
Product Distributed Qty 3972 unit since 4/26/12
Reason For Recall Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations.

Event Detail

Event Id 60480
Product Type Devices
Status Ongoing
Recalling Firm Terumo Cardiovascular Systems Corporation
City Ann Arbor
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-27
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, 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, SC, SD, TN, TX, UT, VA, WA, WI, and WV and the countries of Jordan, CANADA, AUSTRALIA, Japan ,Hong Kong ,UNITED ARAB EMIRATES (UAE), BELGIUM, South Korea, Malaysia, Mexico, Philippines, Singapore, Taiwan, and Thailand.
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