FDA Medical Device Recalls (openFDA)
Bard Medical Division: 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
- Recall number
- Z-0803-2019
- Recalling firm
- Bard Medical Division
- Product
- 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
- Status
- Terminated
- Initiated
- 2018-12-13
- Posted
- 2019-02-06
- Terminated
- 2020-11-02
- Reason
- potential for urine leakage around the vent on the vented sample port
- Root cause
- Device Design
- Action
- Bard sent a Medical Device Notification letter dated December 13, 2018 to affected customers. The letter identified the affected product, problem nd actions to be taken. The distributors were instructed to forward the notice to their affected consignees.
- Quantity
- 883,171 units
- Distribution
- US, Canada, UAE
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K910318"]
- PMA numbers
- not on file
- Product code
- MJC
- Firm FEI
- 1018233
- Firm city
- Covington
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28