CDI Blood Parameter Monitoring System 500 with Arterial and Venous 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 details

Manufacturer

Terumo Cardiovascular Systems Corporation

Distributor

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.

Lot

Catalog number: 500AVHCT* and serial numbers: 0012, 1001-1022, 1024, 1028, 1032, 1033,1036, 1038, 1039, 1041-1044, 1046, 1047,1049-1053,1059,1063,1066-1071,1075,1096,1097,1101-1105, 1111-1304-1309,1312-1315,1321,1332-1334,13401344,1350-1354, 1357, 1358, 1379-1383, 13891393,1399-1408,1414-1418, 1421, 1422, 14241433, 1439-1443, 1449-1453, 1459-1463, 1466,1479, 1480, 1494, 1525, 1554, 1597-1601,1605,1617-1631,1637-1646,1657-1661,16721676,1682-1686,1697-1701,1712-1716, 1733-1737, 1787-1789, 1805-1809, 1815-1819, 1830, 1844-1846, 1857-1860, 1886-1890, 1901-1905,1916-1920, 1926-1930, 1936-1940, 1953-1974,1976-1985, 2029-2034, 2036-2038, 2040, 2045, 2059-2063, 2065-2067, 2070-2077, 2086, 2097-2101, 2109-2111, 2113-2115, 2123-2131, 2138-2142, 2149-2155, 2177-2182, 2185-2187, 2189,2195-2199, 2214, 2216-2219, 2224, 2228-2231, 2243-2245, 2249-2253, 2255-2258, 2260, 2263, 2265-2268, 2275-2277, 2279, 2285-2291, 22952298, 2313-2321, 2323-2329, 2338-2354, 2357, 2366,2368-2375,2377,2392,2403-2408,24172426, 2432-2436, 2439-2444, 2453-2458, 2463-2467, 2470-2472, 2476-2483, 2487-2503, 2514-2517,2521-2525,2541-2556,2565-2582,2587-2603, 2629-2633, 2635-2642, 2646, 2647, 2656, 2661,2662,2664-2680,2689-2691,2695,2696, 2701-2708, 2710-2716, 2722-2727, 2737, 2742-2747, 2757-2773, 2783, 2784, 2788, 2793-2795, 2802,2805-2808,2815-2820,2837-2839,28462849, 2865-2870, 2880-2889, 2892-2895, 2906-2908,2913- 2915,2920,2921,2924-2926, 2937-2940, 2942-2947, 2952, 2958-2975, 2979-2983, 2990-2999, 3008-3010, 3022-3027, 3040, 3041, 3052-3055, 3073-3075, 3083-3087, 3096, 3115, 3116, 3139-3145, 3152, 3153, 3155-3162, 3169-3182, 3190-3196, 3214-3220, 3225-3228, 3232, 3238-3245, 3248, 3249, 3264-3268, 3287, 3288, 3291-3306, 3314-3323, 3329-3334, 3340-3349, 3354-3357, 3369-3373, 3383-3391, 3394-3397, 3402-3406, 3416, 3418-3427, 3434-3437, 34413447, 3449-3456, 3458-3462, 3469-3472, 3481, 3482, 3489, 3490, 3500-3503, 3509, 3510, 3518, 3534, 3535, 3541-3545, 3571-3573, 35903609, 3612-3619, 3624-3628, 3636-3639, 36433645, 3669-3681, 3698-3703, 3715, 3716, 3722-3726, 3738-3744, 3753-3757, 3769-3780, 3784-3787, 3799-3804, 3811-3816, 3827-3830, 3838-3841, 3852-3881, 3892-3899, 3902-3906, 3912-3921, 3924-3931, 3937-3952, 3962-3965, 3971-3974, 3986-3989, 3995-3998, 4006-4029, 4038-1113, 1115, 1130, 1133-1140,1146-1152, 1166-1168, 1181-1185, 1216-1220,1231-1236, 1244-1248,1254,1255,1261-1264, 1270-1274, 1285, 1286-1289, 1295-1299, 4043, 4050-4055, 4070-4075, 4082-4089, 4096-4099,4105-4108,4114-4131,4143-4148,4169-4185, 4203-4212, 4219-4224, 4230-4241, 4260-4280, 4290-4299, 4307-4310, 4318-4323, 4335-4344,4351,4352,5001-5010,5036-5039,5048- 5056, 5065-5077, 5082-5085, 5094-5101, 5118-5125,5142-5149,5158-5169, 5178, 5179, 5190, 5197,5198, 5210-5213,5222-5225,5238-5245, 5250-5253, 5274-5277, 5282-5285, 5290-5293, 5298-5305,5318-5321,5334-5337,5341-5344, 5354-5356, 5370-5374, 5383, 5385, 5386, 5516-5526,5532-5541, 5557-5561, 5584-5592, 5601-5608, and 7992.

Risk classification

Class II

Area (FDA)

device

Country

United States