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Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOT...

FDA Device Recall #Z-0513-2024 — Class I — November 6, 2023

Recall Summary

Recall Number Z-0513-2024
Classification Class I — Serious risk
Date Initiated November 6, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Nurse Assist, LLC
Location Haltom City, TX
Product Type Devices
Quantity 31,850 Cases

Product Description

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 for Recall

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.

Distribution Pattern

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

Lot / Code Information

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, 22114394, 23045247, 23086308, 23096469; 5290/850421008914/23065731, 23065733, 23065811, 23065892; 5280/850421008907/23065735, 23065800, 23065899, 23065919; 4873C/21112462

Other Recalls from Nurse Assist, LLC

Recall # Classification Product Date
Z-0511-2024 Class I 0.9% Sodium Chloride: Brand Name: Product Name/... Nov 6, 2023
Z-0515-2024 Class I Sterile Water: Product Name/Product Code: USP S... Nov 6, 2023
Z-0514-2024 Class I Sterile Water/Saline: Product Name/Product Code... Nov 6, 2023
Z-0512-2024 Class I 0.9% Sodium Chloride: Product Name/Product Code... Nov 6, 2023

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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