FDA Device recall Z-0803-2019
SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300…
- FDA Device
- Class II
- terminated
- Published 2019-02-13
On 2019-02-13 the FDA classified a Class II recall of SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300… by Bard Medical Division, citing potential for urine leakage around the vent on the vented sample port.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0803-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-13 |
| Published | 2019-02-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bard Medical Division |
| Distribution | n/a |
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
Reason
potential for urine leakage around the vent on the vented sample port
Identifiers
| code_info | Product Code, Lot Numbers A119214M, Lot numbers: NGCV3931, NGCV0249 A119216M, Lot numbers: NGCU1498, NGCT3665, NGCU…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0803-2019%22
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