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
A119214MA119216MA119218MA119416MA153200A300916AA301216A301216AA303314AA303316AA303318AA303414AA303416AA303418AA304400AA304714AA304716AA304718AA304914A304916A304918A307414AA307416AA319414AMA319416AA319416AMA319418AMA319514AMA319516AA319516AMA333100AA333416AA339414AMA339516AMA339516AMA344916A800064A800065A800364A800365A800366A900216A900416A901216A902114A902216A902414A902416A902418A902616A902914A902916A902918A903314AA903316AA903318AA903416AA904100A904400AA909116M
- Lot codes and dates
75 of 75 products
Products covered by this recall # Product as published 1 Lot numbers: NGCU1498, NGCT3665, NGCU3726, NGCV0228, NGCV1406, NGCS2897, NGCV2240, NGCV3113, NGCV4031, NGCV3929, NGCW2317, NGCW1354 A119218M 2 Lot numbers: NGCW0723 A119416M 3 Lot numbers: NGCT2589, NGCT3587, NGCT4393, NGCV3007, NGCV2353, NGCV4032, NGCW3267, NGCW3223 A153200 4 Lot numbers: NGCV3160, NGCV2160, NGCV3843, NGCX0557, NGCX0616 A300916A 5 Lot numbers: NGCS3010, NGCT0853, NGCT3709, NGCR2202, NGCW3234 A301216 6 Lot numbers: NGCT3761 A301216A 7 Lot numbers: NGCT1592, NGCV3952, NGCW3191, NGCW3235, NGCX0558 A303314A 8 Lot numbers: NGCT2737, NGCT4265, NGCW1464, NGCV3928, NGCW0629, NGCW3106 A303316A 9 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 10 Lot numbers: NGCT4315, NGCW0890, NGCW3221 A303414A 11 Lot numbers: NGCV1395, NGCT0806, NGCT0859, NGCV1470, NGCW3265, NGCX1509 A303416A 12 Lot numbers: NGCT1950, NGCT2590, NGCT2797, NGCT3586, NGCT4264, NGCV0331, NGCU3735, NGCV0247, NGCV2264, NGCV3933, NGCU3727, NGCV2351, NGCV4034, NGCW0777, NGCW0628 A303418A 13 Lot numbers: NGCV1418 A304400A 14 Lot numbers: NGCT4317, NGCT4278, NGCV2329, NGCT9317, NGCW1355, NGCV3930, NGCW2425 A304714A 15 Lot numbers: NGCW0750 A304716A 16 Lot numbers: NGCV1481, NGCT4313, NGCV2360, NGCW0751, NGCW1472, NGCW3233, NGCX1576 A304718A 17 Lot numbers: NGCT3611, NGCV3021 A304914 18 Lot numbers: NGCW2304 A304916 19 Lot numbers: NGCT4275, NGCV2275, NGCW0643 A304918 20 Lot 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.
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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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