Reported Feb 13, 2019 · Terminated

SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M,…

Bard Medical Division

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bard Medical Division · 8195 Industrial Blvd NE · Covington, GA · 30014-1497

Is this the product you have?

  • SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray
  • Product Codes

    76 of 76 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
Lot codes and dates

75 of 75 products

Products covered by this recall
#Product as published
1Lot numbers: NGCU1498, NGCT3665, NGCU3726, NGCV0228, NGCV1406, NGCS2897, NGCV2240, NGCV3113, NGCV4031, NGCV3929, NGCW2317, NGCW1354 A119218M
2Lot numbers: NGCW0723 A119416M
3Lot numbers: NGCT2589, NGCT3587, NGCT4393, NGCV3007, NGCV2353, NGCV4032, NGCW3267, NGCW3223 A153200
4Lot numbers: NGCV3160, NGCV2160, NGCV3843, NGCX0557, NGCX0616 A300916A
5Lot numbers: NGCS3010, NGCT0853, NGCT3709, NGCR2202, NGCW3234 A301216
6Lot numbers: NGCT3761 A301216A
7Lot numbers: NGCT1592, NGCV3952, NGCW3191, NGCW3235, NGCX0558 A303314A
8Lot numbers: NGCT2737, NGCT4265, NGCW1464, NGCV3928, NGCW0629, NGCW3106 A303316A
9Lot 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
10Lot numbers: NGCT4315, NGCW0890, NGCW3221 A303414A
11Lot numbers: NGCV1395, NGCT0806, NGCT0859, NGCV1470, NGCW3265, NGCX1509 A303416A
12Lot numbers: NGCT1950, NGCT2590, NGCT2797, NGCT3586, NGCT4264, NGCV0331, NGCU3735, NGCV0247, NGCV2264, NGCV3933, NGCU3727, NGCV2351, NGCV4034, NGCW0777, NGCW0628 A303418A
13Lot numbers: NGCV1418 A304400A
14Lot numbers: NGCT4317, NGCT4278, NGCV2329, NGCT9317, NGCW1355, NGCV3930, NGCW2425 A304714A
15Lot numbers: NGCW0750 A304716A
16Lot numbers: NGCV1481, NGCT4313, NGCV2360, NGCW0751, NGCW1472, NGCW3233, NGCX1576 A304718A
17Lot numbers: NGCT3611, NGCV3021 A304914
18Lot numbers: NGCW2304 A304916
19Lot numbers: NGCT4275, NGCV2275, NGCW0643 A304918
20Lot numbers: NGCT2749, NGCW0752 A307414A
Amount recalled
883,171 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Why it was recalled

potential for urine leakage around the vent on the vented sample port

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 2, 2020 · Data as of Sep 19, 6:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.