Recall archive / FDA device enforcement
Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERIL... — FDA record Z-0513-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 6, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE SALINE BOTTLE/1022, 100ML STERILE WATER BOTTLE/1024, 100ML STERILE WATER BOTTLE/10000, 100ML STERILE WATER BOTTLE/PT00103419, 100ML STERILE SALINE BOTTLE/PT00103427; COVIDIEN: STERILE WOUND SOLUTION/90SAL, STERILE WOUND SOLUTION/210SAL; HAYLARD OWENS MINOR: 250ML STERILE WATER BOTTLE/49148, 250ML STERILE SALINE BOTTLE/49152, 1000ML STERILE SALINE BOTTLE/49154, 100ML STERILE SALINE BOTTLE/49155, 1000ML STERILE WATER BOTTLE/49150, 100ML STERILE WATER BOTTLE/49151, 500ML STERILE WATER BOTTLE/49149, 500ML STERILE SALINE BOTTLE/49153; IDEXX: BOTTLE STERILE WATER 10 PACK/98-09444-01; MCKESSON: 100ML STERILE SALINE BOTTLE/37-6240, 500ML STERILE WATER BOTTLE/37-6290, 250ML STERILE SALINE BOTTLE/37-6270, 500ML STERILE SALINE BOTTLE/37-6280, 120ML STERILE WATER CUP/37-6210, 1000ML STERILE SALINE BOTTLE/37-6281, 1000ML STERILE WATER BOTTLE/37-6291, 120ML STERILE SALINE CUP/37-6220, 100ML STERILE WATER BOTTLE/37-6250, 250ML STERILE WATER BOTTLE/37-6260, 210ML SALINE WOUND FLUSH/37-6507, 88.7ML SALINE WOUND FLUSH STERILE/37-6503; MEDICHOICE OWENS MINOR: CAN STERILE SALINE SPRY MEDI 7.1 OZ/SWF071; MEDLINE: 110ML STERILE SALINE CUP/DYND40540, 100ML STERILE SALINE BOTTLE/RDI30296, 250ML STERILE WATER BOTTLE/PCS1550, 250ML STERILE SALINE BOTTLE/PCS1650, 1000ML STERILE SALINE BOTTLE/DYND1000MLS, 100ML STERILE SALINE BOTTLE/52011, 500ML STERILE WATER BOTTLE/DYND500MLW, 500ML STERILE SALINE BOTTLE/DYND500MLS, 100ML STERILE WATER BOTTLE/RDI30295, CAN SALINE STERILE SPRAY CURAD/CURSALINE7, 110ML STERILE WATER CUP/DYND40570, 100ML STERILE WATER BOTTLE/54380; NURSE ASSIST: 100ML STERILE SALINE BOTTLE/6492775, 100ML STERILE WATER BOTTLE/6492776; STERICARE: 90ML USP SALINE WOULD FLUSH/6503, 100ML STERILE SALINE BOTTLE/6240, 100ML STERILE WATER BOTTLE/6250, 250ML STERILE SALINE BOTTLE/6270, 500ML STERILE WATER BOTTLE/6290, 250ML STERILE WATER BOTTLE/6260, 500ML STERILE SALINE BOTTLE/6280, 1000ML STERILE SALINE BOTTLE/6281, 1000ML STERILE WATER BOTTLE/6291, 210ML SALINE WOUND FLUSH/6507, 120ML STERILE SALINE FOIL LID CUP/6220, 120ML STERILE WATER FIOL LID CUP/6210, 500ML STERILE WATER BOTTLE/5290, 500ML STERILE SALINE BOTTLE/5280; VYAIRE: CUP STERILE SALINE FOIL LID 120 ML/4873C
- Reason
- Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
- Classification
- Class I
- Recalling firm
- Nurse Assist, LLC
- Quantity
- 31,850 Cases
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0513-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Product Code/UDI-DI/Lot: 1020/50192253044490/21122619, 22063546, 22094023, 22094028, 22094074, 22094095, 22104138, 23045320, 23076080; 1022/50192253044506/22012651, 22063553, 22083775, 22093943, 22094062, 22104137, 23045338, 23076038, 23076088; 1024/50192253044513/21122618, 22073561, 22093989, 22094122, 23034994, 23045174, 23076031, 23076098; 10000/50192253044520/22073713, 22094086, 22104147, 22104279, 23076079; PT00103419/50192253044513/23076122; PT00103427/50192253044506/23076140, 23086258; 90SAL/20884521140940/22083848; 210SAL/10884521139756/22022771, 22022776, 22114334; 49148/20885632395878/23076067; 49152/20885632395915/23076041; 49154/20885632395939/23076066; 49155/20885632395946/23076057; 49150/20885632395892/23076074; 49151/20885632395908/23076040; 49149/20885632395885/23086163 49153/20885632395922/23086156; 98-09444-01/21112440, 22032932, 22083886, 22104140, 22114339, 22114360, 23065971, 23096487; 37-6240/612479168565/21112357, 21122528, 21122548, 21122575, 21122592, 22012685, 22012686, 22022799, 22022851, 22032904, 22033051, 22043170, 22053283, 22053288, 22053289, 22053320, 22053340, 22053350, 22063460, 22063544, 22073632, 22073677, 22073611, 22083819, 22083851, 22083875, 22083918, 22093952, 22093941, 22093979, 22094096, 22104150, 22104165, 22114282, 22114389, 23014636, 23014707, 23014774, 23024917, 23034942, 23035016, 23035030, 23035064, 23035081, 23035118, 23035140, 23045190, 23045208, 23045264, 23045283, 23055541, 23065812, 23065878, 23065912, 23065939, 23075988, 23086172, 23086267, 23086312, 23086378; 37-6290/612479180314/21102308, 21102312, 21122564, 22022780, 22022796, 22032994, 22033059, 23086203, 23086253; 37-6270/612479168596/21102302, 21122527, 21122547, 21122591, 21122598, 21122612, 22012624, 22032958, 22032991, 22033091, 22043156, 22063426, 22063487, 22063509, 22063522, 22063552, 22073577, 22073606, 22073623, 22073640, 22073673, 22073660, 22073692, 22083794, 22083797, 22083817, 22094016, 22094030, 22094022, 22104180, 22104216, 22114291, 22114308, 22114418, 23014645, 23014682, 23014762, 23024868, 23024909, 23035019, 23035037, 23035141, 23035094, 23045176, 23045232, 23035095, 23045393, 23045414, 23045430, 23055447, 23055479, 23055495, 23055525, 23065759, 23065836, 23065940, 23065951, 23075989, 23075998, 23076010, 23076043, 23076123, 23086220, 23086239, 23086259, 23096388, 23096413, 23096424; 37-6280/612479180307/21102305, 21112401, 22022736, 22022734, 22022755, 22032921, 22032947, 22032965, 22032992, 22033052, 22043147, 23086191, 23086238, 23086261; 37-6210/612479168541/21102252, 22043229, 22053272, 22063536, 22073629, 22083849, 22114410, 22114414, 23045226, 23045236, 23065854, 23086290, 23096453; 37-6281/612479228399/21112452, 21122504, 22012636, 23086173, 23086272, 23086348; 37-6291/612479228405/21112456, 21122616, 21122529, 22012634, 23086178, 23086302, 23086337; 37-6220/612479168558/21122549, 21122613, 22053247, 22063401, 22063429, 22083850, 22114392, 22114424, 23045215, 23045369, 23055616, 23065877, 23086273, 23096425; 37-6250/612479168572/22012640, 22022731, 22022791, 22032960, 22033058, 22053301, 22053335, 22053327, 22053359, 22053361, 22073661, 22073708, 22094019, 22094025, 22094041, 22104148, 23014649, 23014756, 23024937, 23035050, 23035166, 23045177, 23045225, 23045311, 23055592, 23065960, 23086190, 23086289; 37-6260/612479168589/22022737, 22022756, 22032948, 21122555, 22063471, 22063499, 22063513, 22063549, 22073578, 22073592, 22073704, 22083769, 22094018, 22094026, 22124451, 23014598, 23024851, 23024893, 23035046, 23035111, 23035138, 23035156, 23045182, 23045199, 23045214, 23055614, 23075980, 23076009, 23076021, 23076036, 23096426, 23096437; 37-6507/612479133761/22043122, 22043169, 22043239, 23045234, 23045251, 23045260, 23076017; 37-6503/612479228429/22083835; SWF071/50885632127043/22022738, 22022758, 22114327, 23024933, 23034989, 23035054, 23076008; DYND40540/40884389334233/21112358, 21112381, 21122577, 22022748, 22053258, 22053285, 22053334, 22053329, 22053383, 22073728, 22083763, 22083767, 22083788, 22083818, 22083871, 22124459, 22124488, 23014591, 23045298, 23045322, 23045428, 23055440, 23055536, 23055545, 23055555, 23055647, 23055656, 23055672, 23055699; RDI30296/40884389338248/21112391, 21112458, 22012676, 22012722, 22022811, 22032868, 22022810, 22032924, 22032959, 22032972, 22033082, 22043132, 22043190, 22043211, 22053266, 22053271, 22053287, 22053305, 22053325, 22053356, 22053366, 22063385, 22063438, 22063457, 22063468, 22063507, 22063521, 22063550, 22073590, 22073659, 22073695, 22083760, 22083846, 22083868, 22083874, 22093954, 22093990, 22094002, 22094003, 22094048, 22094059, 22104199, 22104244, 22104263, 22114283, 22114303, 23014568, 23014650, 23014694, 23014723, 23014745, 23024787, 23024821, 23024885, 23035041, 23035103, 23035157, 23055461, 23055681; PCS1550/40080196427056/21112394, 21112423, 21122516, 21122501, 21122517, 22012639, 22022813, 22012726, 22033021, 22033103, 22043145, 22043133, 22043185, 22063441, 22073589, 22073682, 22073690, 22073714, 22073727, 22083787, 22083795, 22083832, 22083796, 22083860, 22083873, 22083869, 22083895, 22083890, 22083897, 22083930, 23014703, 23024830, 23045269, 23045295, 23055462, 23055485, 23055533, 23055546, 23055652, 23055728, 23055719; PCS1650/40884389338262/21112398, 21112457, 21112460, 21112463, 22012725, 22022808, 22022812, 22022854, 22032973, 22032993, 22033081, 22043121, 22043128, 22063442, 22063456, 22063449, 22063466, 22073678, 22093953, 22093942, 22093966, 22093978, 22093988, 22094063, 22094073, 22094094, 22094087, 22104169, 22104208, 23014569, 23014580, 23014667, 23014739, 23014751, 23024779, 23024818, 23024878, 23045293, 23055484, 23055494, 23055562, 23055593, 23055642, 23055673, 23055685, 23055710, 23065745; DYND1000MLS/208882776699466/21112415/21112411; 52011/21112453, 22033018, 22043183, 22073571, 22093967; DYND500MLW/40884389118390/21112481, 22033053, 22033076, 22043127, 22043130, 22043171, 22043182, 22043212, 22043250, 22104181, 22114406, 23034983; DYND500MLS/40884389118406/21112387, 21122565, 22032920, 22033031, 22033060, 22043189, 22043199, 22043226, 22043232, 22043242, 22104152, 22104176, 22104189, 22104217, 22114393, 22114401, 23034984; RDI30295/40884389338231/22012724, 22032893, 22033092, 22053303, 22053328, 22053337, 22053363, 22063417, 22063530, 22073613, 22073628, 22083901, 22083912, 22094075, 22104166, 22114310, 23024839, 23024879, 23035008, 23045397; CURSALINE7/40080196297970/22032903, 22022763, 22033093, 22043097; DYND40570/40884389334226/22053264, 22053286, 22053304, 22053321, 22053362, 22063551, 22073645, 22073688, 22073707, 22124441, 22124450, 22124523, 23014567, 23014629, 23045343, 23055454, 23055482, 23055601, 23055627; 54380/22073723, 22083761, 22083768, 22114372, 23055676; 6492775/B15064927754G/21112412, 21112413, 22012646, 22012716, 22022739, 22043108, 22063393, 22073588, 22073591, 22073725, 22073731, 22083831, 22104231, 22104245, 23024808; 6492776/B15064927764H/22043196, 22043225, 22104268; 6503/10850421008751/21102284, 22083859; 6240/10850421008812/21112395, 21112421, 21102310, 21112464, 21122553, 21122608, 22012720, 22032939, 22032953, 22033020, 22033030, 22043198, 22053367, 22063418, 22063436, 22063480, 22063515, 22073614, 22073679, 22073711, 22083764, 22083839, 22083898, 22083928, 22083929, 22093965, 22093977, 22094021, 22094029, 22094085, 22094107, 22104215, 22104233, 22114329, 22124544, 23014603, 23024895, 23024921, 23035031, 23035052, 23035093, 23045346, 23055612, 23065785, 23065855, 23076014, 23076042; 6250/10850421008768/21112397, 22022792, 22063448, 22063508, 22063529, 22083774, 22083891, 23024853, 23034964, 23045382, 23086222, 23096389; 6270/10850421008829/21112437, 22012625, 22012713, 22012717, 22022793, 22022867, 22032869, 22053357, 22063397, 22063427, 22073603, 22073612, 22073627, 22073641, 22073710, 22073709, 22073726, 22083793, 22083847, 22083903, 22083916, 22083925, 22094004, 22094047, 22094106, 22104151, 22104198, 22104247, 22104262, 22114324, 22114337, 22114369, 22114381, 22114431, 22114439, 22124458, 22124473, 22124487, 22124524, 22124540, 22124547, 23014722, 23024800, 23024883, 23024916, 23035079, 23035089, 23045351, 23045429, 23055519, 23055547, 23055604, 23065850, 23065930, 23065962, 23076050, 23076070, 23076083, 23086194, 23086230, 23096421, 23096438, 23096455, 23096475; 6290/10850421008782/21102214, 21122546, 22022728, 22094118, 22104136, 22114416, 22114432, 22124472, 22124531, 22124541, 23014565, 23014576, 23014640, 23014655, 23014669, 23014704, 23014717, 23014729, 23014741, 23014738, 23014749, 23014765, 23014757, 23014775, 23024782, 23024811, 23024820, 23024869, 23024886, 23024880, 23024890, 23024913, 23024912, 23024925, 23024939, 23024936, 23034941, 23034952, 23035004, 23035015, 23035027, 23035040, 23035045, 23035088, 23035139, 23035131, 23035142, 23035167, 23035168, 23045175, 23045224, 23045211, 23045233, 23045257, 23045263, 23045271, 23045268, 23045413, 23045427, 23045424, 23055435, 23055441, 23055520, 23055493, 23055579, 23055586, 23055591, 23055607, 23055599, 23055621, 23055615, 23055675, 23055667, 23055693, 23065786, 23065798, 23065803, 23065837, 23065845, 23065849, 23065913, 23065908, 23065920, 23065935, 23065926, 23065946, 23065961, 23065952, 23065966, 23076006, 23076020, 23076029, 23076026, 23076037, 23076109, 23076113, 23076124, 23076115, 23076142, 23086179, 23086197, 23086240, 23086250, 23086262, 23086257, 23086269, 23086275, 23086299, 23086364, 23086376, 23086379, 23096390, 23096416, 23096422, 23096428, 23096471, 23096464, 23096473, 23096492, 23096482; 6260/10850421008775/21092009, 21122574, 22012687, 22022779, 22032894, 22053348, 22043099, 22053360, 22073568, 22073729, 22083759, 22083765, 22104192, 22104232, 22104241, 22114391, 22114409, 22114400, 22114417, 22124498, 22124512, 23024789, 23035058, 23035083, 23045262, 23045373, 23045415, 23065767, 23065972, 23076073, 23086153, 23086200, 23086368, 23096440; 6280/10850421008836/21122490, 21122531, 22022727, 22043155, 22053246, 22094123, 22104139, 22124440, 22124449, 22124457, 22124501, 22124486, 22124511, 22124518, 22124545, 22124557, 23014592, 23014609, 23014626, 23014684, 23014680, 23024790, 23024799, 23024829, 23024852, 23024840, 23024866, 23024894, 23024903, 23034982, 23034986, 23034985, 23034962, 23034990, 23034988, 23035007, 23034998, 23035014, 23035053, 23035059, 23035067, 23035096, 23035119, 23035109, 23035126, 23035144, 23035152, 23045189, 23045181, 23045198, 23045206, 23045246, 23045282, 23045272, 23045301, 23045316, 23045333, 23045356, 23045352, 23045364, 23045374, 23045392, 23055452, 23055470, 23055483, 23055503, 23055532, 23055544, 23055565, 23055553, 23055578, 23055575, 23055628, 23055648, 23055641, 23055657, 23065746, 23065754, 23065762, 23065774, 23065781, 23065809, 23065822, 23065856, 23065866, 23065883, 23065871, 23065895, 23065889, 23065904, 23065900, 23075979, 23075985, 23076059, 23076112, 23076120, 23076143, 23086167, 23086192, 23086217, 23086209, 23086221, 23086234, 23086281, 23086316, 23086306, 23086325, 23086332, 23086352, 23086339, 23086349, 23086367, 23086363, 23086381, 23096387, 23096406, 23096435, 23096454, 23096448, 23096489; 6281/10850421008843/21092166, 21122518, 21112465, 22022856, 22033027, 22033037, 22104280, 22104264, 22114311, 22124474, 23034940, 23034953, 23034968, 23055727, 23055720, 23065787, 23065924, 23065936, 23076077, 23076089, 23076099, 23086162, 23086293, 23086298, 23096476; 6291/10850421008799/21122611, 21122615, 22022855, 22022861, 22104267, 22114302, 22114294, 22114288, 22114304, 22114348, 22114336, 22114353, 22114350, 22114359, 22114367, 22114362, 22114375, 22114371, 22124479, 23024934, 23024932, 23024938, 23055677, 23055700, 23055713, 23065729, 23065734, 23065743, 23065749, 23065777, 23076110, 23086307, 23086326; 6507/10850421008744/22012714, 22022730, 22012721, 22022732, 22022757, 23045284, 23045321, 23075987; 6220/10850421008874/22022852, 22032881, 22063437, 22063447, 22063497, 22073607, 22073622, 23045173, 23045187, 23045277, 23045388, 23045405, 23055716, 23086288, 23096441; 6210/10850421008867/22063547, 22063545... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide Distribution: SC AZ, CA, FL, GA, HI, IA, IN, KS, KY, MA, ME, MN, MS, NC, ND, NE, NJ, NV, NY, OH, PA, RI, TX, WA, WI, AK, AL, AR, CO, CT, DC, ID, IL, LA, MD, MI, MO, MT, NH, NM, OK, OR, PR, SD, TN, UT, VA , WI, WV, WY. OUS (foreign) distribution to: Canada
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Dec 27, 2023
- Recall initiation date
- Nov 6, 2023
- Center classification date
- Dec 20, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.