🔍 RecallPedia

SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A304916, A304918, A307414A, A307416A, A319414AM, A319416A, A319416AM, A319418AM, A319514AM, A319516A, A319516AM, A333100A, A333416A, A339414AM, A339516AM, A339516AM, A344916, A800064, A800065, A800364, A800365, A800366, A900216, A900416, A901216, A902114, A902216, A902414, A902416, A902418, A902616, A902914, A902916, A902918, A903314A, A903316A, A903318A, A903416A, A904100, A904400A, A909116M, A909216M, A919416AM, A919516AM, A942206, A942208, A942210, A942212, A942214, A942216, A942218, A942616, A942618, A943214, A943216, A943218, MTA902416 Product Usage catheter

Class I - Dangerous
🏥 Medical Devices Recalled: December 13, 2018 Bard Medical Division Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Product Code, Lot Numbers A119214M, Lot numbers: NGCV3931, NGCV0249 A119216M, Lot numbers: NGCU1498, NGCT3665, NGCU3726, NGCV0228, NGCV1406, NGCS2897, NGCV2240, NGCV3113, NGCV4031, NGCV3929, NGCW2317, NGCW1354 A119218M, Lot numbers: NGCW0723 A119416M, Lot numbers: NGCT2589, NGCT3587, NGCT4393, NGCV3007, NGCV2353, NGCV4032, NGCW3267, NGCW3223 A153200, Lot numbers: NGCV3160, NGCV2160, NGCV3843, NGCX0557, NGCX0616 A300916A, Lot numbers: NGCS3010, NGCT0853, NGCT3709, NGCR2202, NGCW3234 A301216, Lot numbers: NGCT3761 A301216A, Lot numbers: NGCT1592, NGCV3952, NGCW3191, NGCW3235, NGCX0558 A303314A, Lot numbers: NGCT2737, NGCT4265, NGCW1464, NGCV3928, NGCW0629, NGCW3106 A303316A, Lot numbers: NGCV1474, NGCV1476, NGCV2273, NGCV2274, NGCV3005, NGCV3006, NGCT2587, NGCT2588, NGCT2591, NGCT2738, NGCT3672, NGCT3608, NGCT3674, NGCT3609, NGCT4266, NGCT4267, NGCT4305, NGCT4304, NGCT2742, NGCT2739, NGCT4306, NGCV2361, NGCV3372, NGCV3938, NGCV3341, NGCV3932, NGCW1356, NGCW1358, NGCW1359, NGCW1467, NGCV4039, NGCV3937, NGCW0630, NGCW0724, NGCW2306, NGCW3067, NGCW2307, NGCW3225, NGCW3226, NGCW3109, NGCW3268 A303318A, Lot numbers: NGCT4315, NGCW0890, NGCW3221 A303414A, Lot numbers: NGCV1395, NGCT0806, NGCT0859, NGCV1470, NGCW3265, NGCX1509 A303416A, Lot numbers: NGCT1950, NGCT2590, NGCT2797, NGCT3586, NGCT4264, NGCV0331, NGCU3735, NGCV0247, NGCV2264, NGCV3933, NGCU3727, NGCV2351, NGCV4034, NGCW0777, NGCW0628 A303418A, Lot numbers: NGCV1418 A304400A, Lot numbers: NGCT4317, NGCT4278, NGCV2329, NGCT9317, NGCW1355, NGCV3930, NGCW2425 A304714A, Lot numbers: NGCW0750 A304716A, Lot numbers: NGCV1481, NGCT4313, NGCV2360, NGCW0751, NGCW1472, NGCW3233, NGCX1576 A304718A, Lot numbers: NGCT3611, NGCV3021 A304914, Lot numbers: NGCW2304 A304916, Lot numbers: NGCT4275, NGCV2275, NGCW0643 A304918, Lot numbers: NGCT2749, NGCW0752 A307414A, Lot numbers: NGCT1956, NGCW1365 A307416A, Lot numbers: NGCV1433, NGCW0644, NGCW1474 A319414AM, Lot numbers: NGCT2581, NGCW1350, NGCV4035, NGCX0536 A319416A, Lot numbers: NGCT1944, NGCT2628, NGCT3677, NGCT4318, NGCV2364, NGCW0754, NGCX1578 A319416AM, Lot numbers: NGCV1409, NGCT1932, NGCT2741, NGCT2743, NGCT3610, NGCT4233, NGCV2354, NGCV3114, NGCW0631, NGCW0725, NGCW0726, NGCV3934, NGCV4036, NGCW1468, NGCW3113, NGCW2426, NGCW2320, NGCX1510 A319418AM, Lot numbers: NGCT1929 A319514AM, Lot numbers: NGCS1878, NGCV0328, NGCW3070, NGCV1860, NGCV3115, NGCV1471 A319516A, Lot numbers: NGCS4476, NGCT1962, NGCU3547, NGCU3741, NGCW1366, NGCV4043 A319516AM, Lot numbers: NGCS4470, NGCS2898, NGCT1935, NGCU2366, NGCU1452, NGCU1446, NGCU3724, NGCV0245, NGCV0329, NGCV1469, NGCV1391, NGCV1468, NGCV2328, NGCV3134, NGCV3936, NGCV4037, NGCW0729, NGCW1475 A333100A, Lot numbers: NGCT1960 A333416A, Lot numbers: NGCT1945 A339414AM, Lot numbers: NGCT4319 A339516AM, Lot numbers: NGCU2246 A339516AM, Lot numbers: NGCX0546 A344916, Lot numbers: NGCT4320 A800064, Lot numbers: NGCV1191, NGCS4478, NGCT4273, NGCX0603 A800065, Lot numbers: NGCW1466 A800364, Lot numbers: NGCT4230, NGCW0633, NGCW0730, NGCV3010, NGCV3935, NGCW1458, NGCW3066 A800365, Lot numbers: NGCV1422, NGCV1419, NGCV1477, NGCV1478, NGCV2267, NGCV2355, NGCT3614, NGCT4268, NGCT4228, NGCT2429, NGCT2583, NGCT2582, NGCT2734, NGCT2732, NGCT2733, NGCT4389, NGCV3135, NGCV3136, NGCW1349, NGCV4033, NGCV4040, NGCW2322, NGCW2321, NGCW2428, NGCW2427, NGCW2323, NGCW3244, NGCW3266, NGCW3245 A800366, Lot numbers: NGCT2593, NGCV3137 A900216, Lot numbers: NGCV1438, NGCX0617 A900416, Lot numbers: NGCT3767, NGCV3844, NGCX1620 A901216, Lot numbers: NGCV2183, NGCX0530 A902114, Lot numbers: NGCT1930, NGCV3166 A902216, Lot numbers: NGCV2268, NGCW1362 A902414, Lot numbers: NGCV1854, NGCT2585, NGCV4030, NGCW2429 A902416, Lot numbers: NGCV1479, NGCT1936, NGCT1953, NGCV3013, NGCV2271, NGCV2359, NGCW0731, NGCW1352, NGCW0634, NGCW0635, NGCV4038, NGCW2385, NGCW2464, NGCW2465 A902418, Lot numbers: NGCT1933, NGCW1461 A902616, Lot numbers: NGCT2755, NGCT3676, NGCT4279 A902914, Lot numbers: NGCT2754, NGCV2265, NGCW0749 A902916, Lot numbers: NGCV2270, NGCV2269, NGCV2356, NGCV2357, NGCV2358, NGCT2594, NGCT2595, NGCT2744, NGCT2745, NGCT3669, NGCT3588, NGCT3589, NGCT3667, NGCT4269, NGCT4270, NGCT4307, NGCT3592, NGCT3666, NGCT3675, NGCT4308, NGCU1348, NGCV3019, NGCV3143, NGCV3144, NGCV3138, NGCV4041, NGCW1361, NGCW1470, NGCW1469, NGCV4042, NGCV3939, NGCV3941, NGCV3940, NGCW2494, NGCW2386, NGCW2302, NGCW2387, NGCW1360, NGCW3188 A902918, Lot numbers: NGCW0637, NGCW2303 A903314A, Lot numbers: NGCT1959, NGCW1471 A903316A, Lot numbers: NGCS2933, NGCT4312, NGCW1363, NGCX1573 A903318A, Lot numbers: NGCT0864 A903416A, Lot numbers: NGCT3679, NGCV2362 A904100, Lot numbers: NGCW0646 A904400A, Lot numbers: NGCV3050, NGCW3187 A909116M, Lot numbers: NGCV1194 A909216M, Lot numbers: NGCT4314, NGCX0609 A919416AM, Lot numbers: NGCT1946, NGCT3664, NGCT4274 A919516AM, Lot numbers: NGCT2584, NGCT0814, NGCU2245 A942206, Lot numbers: NGCV1445 A942208, Lot numbers: NGCT2756, NGCW1364 A942210, Lot numbers: NGCV1366, NGCW2411 A942212, Lot numbers: NGCW1473 A942214, Lot numbers: NGCV1426, NGCT2735, NGCT1963, NGCV3421 A942216, Lot numbers: NGCT4272, NGCU1512, NGCU1513, NGCV1428, NGCV1480, NGCT1934, NGCV2266, NGCV1855, NGCV2352, NGCV3020, NGCW1351, NGCV3145, NGCW0647, NGCW1459, NGCW1386, NGCW2409 A942218, Lot numbers: NGCV1446, NGCV3167, NGCW1460 A942616, Lot numbers: NGCT2748, NGCV2291 A942618, Lot numbers: NGCV1367 A943214, Lot numbers: NGCT0810 A943216, Lot numbers: NGCV1447, NGCT2620, NGCT3615, NGCV2365, NGCW0756, NGCW2308 A943218, Lot numbers: NGCT1943 MTA902416, Lot numbers: NGCU2625, NGCU2626
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Bard Medical Division
Reason for Recall:
potential for urine leakage around the vent on the vented sample port
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A304916, A304918, A307414A, A307416A, A319414AM, A319416A, A319416AM, A319418AM, A319514AM, A319516A, A319516AM, A333100A, A333416A, A339414AM, A339516AM, A339516AM, A344916, A800064, A800065, A800364, A800365, A800366, A900216, A900416, A901216, A902114, A902216, A902414, A902416, A902418, A902616, A902914, A902916, A902918, A903314A, A903316A, A903318A, A903416A, A904100, A904400A, A909116M, A909216M, A919416AM, A919516AM, A942206, A942208, A942210, A942212, A942214, A942216, A942218, A942616, A942618, A943214, A943216, A943218, MTA902416 Product Usage catheter

Product Codes/Lot Numbers:

Product Code, Lot Numbers A119214M, Lot numbers: NGCV3931, NGCV0249 A119216M, Lot numbers: NGCU1498, NGCT3665, NGCU3726, NGCV0228, NGCV1406, NGCS2897, NGCV2240, NGCV3113, NGCV4031, NGCV3929, NGCW2317, NGCW1354 A119218M, Lot numbers: NGCW0723 A119416M, Lot numbers: NGCT2589, NGCT3587, NGCT4393, NGCV3007, NGCV2353, NGCV4032, NGCW3267, NGCW3223 A153200, Lot numbers: NGCV3160, NGCV2160, NGCV3843, NGCX0557, NGCX0616 A300916A, Lot numbers: NGCS3010, NGCT0853, NGCT3709, NGCR2202, NGCW3234 A301216, Lot numbers: NGCT3761 A301216A, Lot numbers: NGCT1592, NGCV3952, NGCW3191, NGCW3235, NGCX0558 A303314A, Lot numbers: NGCT2737, NGCT4265, NGCW1464, NGCV3928, NGCW0629, NGCW3106 A303316A, Lot numbers: NGCV1474, NGCV1476, NGCV2273, NGCV2274, NGCV3005, NGCV3006, NGCT2587, NGCT2588, NGCT2591, NGCT2738, NGCT3672, NGCT3608, NGCT3674, NGCT3609, NGCT4266, NGCT4267, NGCT4305, NGCT4304, NGCT2742, NGCT2739, NGCT4306, NGCV2361, NGCV3372, NGCV3938, NGCV3341, NGCV3932, NGCW1356, NGCW1358, NGCW1359, NGCW1467, NGCV4039, NGCV3937, NGCW0630, NGCW0724, NGCW2306, NGCW3067, NGCW2307, NGCW3225, NGCW3226, NGCW3109, NGCW3268 A303318A, Lot numbers: NGCT4315, NGCW0890, NGCW3221 A303414A, Lot numbers: NGCV1395, NGCT0806, NGCT0859, NGCV1470, NGCW3265, NGCX1509 A303416A, Lot numbers: NGCT1950, NGCT2590, NGCT2797, NGCT3586, NGCT4264, NGCV0331, NGCU3735, NGCV0247, NGCV2264, NGCV3933, NGCU3727, NGCV2351, NGCV4034, NGCW0777, NGCW0628 A303418A, Lot numbers: NGCV1418 A304400A, Lot numbers: NGCT4317, NGCT4278, NGCV2329, NGCT9317, NGCW1355, NGCV3930, NGCW2425 A304714A, Lot numbers: NGCW0750 A304716A, Lot numbers: NGCV1481, NGCT4313, NGCV2360, NGCW0751, NGCW1472, NGCW3233, NGCX1576 A304718A, Lot numbers: NGCT3611, NGCV3021 A304914, Lot numbers: NGCW2304 A304916, Lot numbers: NGCT4275, NGCV2275, NGCW0643 A304918, Lot numbers: NGCT2749, NGCW0752 A307414A, Lot numbers: NGCT1956, NGCW1365 A307416A, Lot numbers: NGCV1433, NGCW0644, NGCW1474 A319414AM, Lot numbers: NGCT2581, NGCW1350, NGCV4035, NGCX0536 A319416A, Lot numbers: NGCT1944, NGCT2628, NGCT3677, NGCT4318, NGCV2364, NGCW0754, NGCX1578 A319416AM, Lot numbers: NGCV1409, NGCT1932, NGCT2741, NGCT2743, NGCT3610, NGCT4233, NGCV2354, NGCV3114, NGCW0631, NGCW0725, NGCW0726, NGCV3934, NGCV4036, NGCW1468, NGCW3113, NGCW2426, NGCW2320, NGCX1510 A319418AM, Lot numbers: NGCT1929 A319514AM, Lot numbers: NGCS1878, NGCV0328, NGCW3070, NGCV1860, NGCV3115, NGCV1471 A319516A, Lot numbers: NGCS4476, NGCT1962, NGCU3547, NGCU3741, NGCW1366, NGCV4043 A319516AM, Lot numbers: NGCS4470, NGCS2898, NGCT1935, NGCU2366, NGCU1452, NGCU1446, NGCU3724, NGCV0245, NGCV0329, NGCV1469, NGCV1391, NGCV1468, NGCV2328, NGCV3134, NGCV3936, NGCV4037, NGCW0729, NGCW1475 A333100A, Lot numbers: NGCT1960 A333416A, Lot numbers: NGCT1945 A339414AM, Lot numbers: NGCT4319 A339516AM, Lot numbers: NGCU2246 A339516AM, Lot numbers: NGCX0546 A344916, Lot numbers: NGCT4320 A800064, Lot numbers: NGCV1191, NGCS4478, NGCT4273, NGCX0603 A800065, Lot numbers: NGCW1466 A800364, Lot numbers: NGCT4230, NGCW0633, NGCW0730, NGCV3010, NGCV3935, NGCW1458, NGCW3066 A800365, Lot numbers: NGCV1422, NGCV1419, NGCV1477, NGCV1478, NGCV2267, NGCV2355, NGCT3614, NGCT4268, NGCT4228, NGCT2429, NGCT2583, NGCT2582, NGCT2734, NGCT2732, NGCT2733, NGCT4389, NGCV3135, NGCV3136, NGCW1349, NGCV4033, NGCV4040, NGCW2322, NGCW2321, NGCW2428, NGCW2427, NGCW2323, NGCW3244, NGCW3266, NGCW3245 A800366, Lot numbers: NGCT2593, NGCV3137 A900216, Lot numbers: NGCV1438, NGCX0617 A900416, Lot numbers: NGCT3767, NGCV3844, NGCX1620 A901216, Lot numbers: NGCV2183, NGCX0530 A902114, Lot numbers: NGCT1930, NGCV3166 A902216, Lot numbers: NGCV2268, NGCW1362 A902414, Lot numbers: NGCV1854, NGCT2585, NGCV4030, NGCW2429 A902416, Lot numbers: NGCV1479, NGCT1936, NGCT1953, NGCV3013, NGCV2271, NGCV2359, NGCW0731, NGCW1352, NGCW0634, NGCW0635, NGCV4038, NGCW2385, NGCW2464, NGCW2465 A902418, Lot numbers: NGCT1933, NGCW1461 A902616, Lot numbers: NGCT2755, NGCT3676, NGCT4279 A902914, Lot numbers: NGCT2754, NGCV2265, NGCW0749 A902916, Lot numbers: NGCV2270, NGCV2269, NGCV2356, NGCV2357, NGCV2358, NGCT2594, NGCT2595, NGCT2744, NGCT2745, NGCT3669, NGCT3588, NGCT3589, NGCT3667, NGCT4269, NGCT4270, NGCT4307, NGCT3592, NGCT3666, NGCT3675, NGCT4308, NGCU1348, NGCV3019, NGCV3143, NGCV3144, NGCV3138, NGCV4041, NGCW1361, NGCW1470, NGCW1469, NGCV4042, NGCV3939, NGCV3941, NGCV3940, NGCW2494, NGCW2386, NGCW2302, NGCW2387, NGCW1360, NGCW3188 A902918, Lot numbers: NGCW0637, NGCW2303 A903314A, Lot numbers: NGCT1959, NGCW1471 A903316A, Lot numbers: NGCS2933, NGCT4312, NGCW1363, NGCX1573 A903318A, Lot numbers: NGCT0864 A903416A, Lot numbers: NGCT3679, NGCV2362 A904100, Lot numbers: NGCW0646 A904400A, Lot numbers: NGCV3050, NGCW3187 A909116M, Lot numbers: NGCV1194 A909216M, Lot numbers: NGCT4314, NGCX0609 A919416AM, Lot numbers: NGCT1946, NGCT3664, NGCT4274 A919516AM, Lot numbers: NGCT2584, NGCT0814, NGCU2245 A942206, Lot numbers: NGCV1445 A942208, Lot numbers: NGCT2756, NGCW1364 A942210, Lot numbers: NGCV1366, NGCW2411 A942212, Lot numbers: NGCW1473 A942214, Lot numbers: NGCV1426, NGCT2735, NGCT1963, NGCV3421 A942216, Lot numbers: NGCT4272, NGCU1512, NGCU1513, NGCV1428, NGCV1480, NGCT1934, NGCV2266, NGCV1855, NGCV2352, NGCV3020, NGCW1351, NGCV3145, NGCW0647, NGCW1459, NGCW1386, NGCW2409 A942218, Lot numbers: NGCV1446, NGCV3167, NGCW1460 A942616, Lot numbers: NGCT2748, NGCV2291 A942618, Lot numbers: NGCV1367 A943214, Lot numbers: NGCT0810 A943216, Lot numbers: NGCV1447, NGCT2620, NGCT3615, NGCV2365, NGCW0756, NGCW2308 A943218, Lot numbers: NGCT1943 MTA902416, Lot numbers: NGCU2625, NGCU2626

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0803-2019

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