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Sterile Water/Saline: Brand Name: Product Name/Product Code recallZ-0513-2024 · Nurse Assist, LLC · initiated Nov 6, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Nurse Assist, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

On 11/6/23, the firm issued a press release. On 11/09/23, "URGENT: MEDICAL DEVICE RECALL" notices and response forms were emailed and mailed to direct customers and distributors, who were provided with a separate customer recall notice they could forward to their customers. Customers were asked to do the following: 1) Quarantine and then return affected devices. 2) If affected products were further distributed, send these customers the attached recall notice that asks customers to return affected devices to their distributors. 3) Distributors are asked to follow up with customers to ensure they received the recall notification and are taking appropriate action. 4) Distributors are asked to provide their Customer Shipment Report that lists all devices shipped to customers. The report should include the Shipment Date, Customer Name and Address, Part Number, Lot Number, and Quantity. This information is important to determine removal effectiveness. 5) Complete and return the response form via email to [email protected] 6) If your company repacked these medical devices into convenience kits, please contact your local FDA recall coordinator to evaluate the need for a new recall. The firm is arranging for removal and replacement of the affected product. The recall notice sent by distributors to their customers also asks that the notice be forwarded to the applicable personnel in their organization or to any organization where the Affected Devices were transferred. Customers with questions can call 800-649-6800, between the hours of 8am and 4:30pm (CST), or email [email protected]

Recall details

Recall number
Z-0513-2024
Status
Open, Classified
Initiated by the company
Nov 6, 2023
Posted by the FDA
Dec 20, 2023
Recalling firm
Nurse Assist, LLC
Quantity
31,850 Cases
Product code
FRO
FDA submissions
K083042
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

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

Code information (models, lots, serial numbers)

Show the full code information (12k characters)

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

Devices named in this recall

37 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K083042 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93434).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page