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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93434

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 06, 2023
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Nurse Assist, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP; SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001; HALYARD OWENS MINOR: 0.9% USP SODIUM CHLORIDE INJECTION/SS003, 0.9% USP SODIUM CHLORIDE INJECTION/SS005, 0.9% USP SODIUM CHLORIDE INJECTION/SS010, 10ML SYRINGE STERILE/SS010SFR

Z-0511-2024
Recall number
Z-0511-2024
Initiated
November 06, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Nurse Assist, LLC
Quantity
61,740 Cases

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Code/UDI-DI/Lot: 9210/20850020865042/21122520, 21122573, 22032938; 1203-BP/B1501203BP4/22022797; 1205-BP/B1501205BP4/22022789, 23024788; 1210-BP/B1501210BP4/21112359, 21112384, 21112388, 21112441, 21112451, 21122519, 21122550, 21122588, 21122614, 22012632, 22012669, 22012668, 22012672, 22012673, 22012677, 22012689, 21122572, 22012678, 22022824, 22012690, 22022827, 22022853, 22022857, 22032891, 22032923, 22032922, 22032935, 22032936, 22032937, 22032962, 22033016, 22032963, 22033026, 22033038, 22033061, 22033083, 22043095, 22043129, 22043135, 22043154, 22043172, 22043186, 22043210, 22043214, 22043227, 22043240, 22043253, 22053259, 22053270, 22053260, 22053282, 22053281, 22053293, 22053306, 22053333, 22053326, 22053341, 22053364, 22053382, 22063384, 22063411, 22063428, 22063416, 22063459, 22063481, 22063510, 22063523, 22063538, 22063554, 22073576, 22073596, 22073626, 22073668, 22073712, 22083756, 22083766, 22083798, 22083830, 22083894, 22083899, 22083917, 22093934, 22093951, 22093983, 22094015, 22094027, 22094057, 22094058, 22094076, 22094097, 22094121, 22104141, 22104149, 22104168, 22104182, 22104200, 22104226, 22104246, 22104278, 22114301, 22114328, 22114349, 22114366, 22114390, 22114413, 22114433, 22124485, 22124510, 22124529, 23014706, 23014528, 23014755, 23024867, 23045258, 23055569, 23065893, 23065922, 23086215, 23086351, 23096407; PFF001/20810062438895/23014656, 23014671; SS003/20885632389778/23035163, 23055622, 23086334; SS005/20885632389761/23035151, 23055649, 23076007, 23086323; SS010/20885632389754/23024926, 23035099, 23035143, 23045223, 23045305, 23055455, 23055658, 23065737, 23065794, 23065853, 23065958, 23065967, 23075984, 23076039, 23076086, 23076105, 23076121, 23086157, 23086189, 23086248, 23086264; SS010SFR/not distributed.

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

device · product 2 of 5

0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240

Z-0512-2024
Recall number
Z-0512-2024
Initiated
November 06, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Nurse Assist, LLC
Quantity
3,360 Cases

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Code/UDI-DI/Lot: EMZ10091240/20363807109166/21112364, 21112439, 21112455, 21122507, 21122551, 21122576, 21122593, 21122609, 21122617, 22012635, 22073671, 22094119, 22104179, 22104234

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

device · product 3 of 5

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

Z-0513-2024
Recall number
Z-0513-2024
Initiated
November 06, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Nurse Assist, LLC
Quantity
31,850 Cases

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

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

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

device · product 4 of 5

Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿ FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID 120 ML/T167007

Z-0514-2024
Recall number
Z-0514-2024
Initiated
November 06, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Nurse Assist, LLC
Quantity
432 Cases

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Code/Lot: T167005/22022859, 22083878, 23055524; T167007/21122503, 22022860, 22083862, 22114365, 23045255, 23045267

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

device · product 5 of 5

Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/51638, 30CC PREFILLED SYRINGES/52333, 10CC PREFILLED SYRINGES/1010

Z-0515-2024
Recall number
Z-0515-2024
Initiated
November 06, 2023
Classification
Class I
Status
Ongoing
Recalling firm
Nurse Assist, LLC
Quantity
15,800 Cases

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Code/UDI-DI/Lot: 1030A/B1501030A4/2001155, 2003041, 2005126, 2008103, 2102502, 2102567, 2102580, 2102600, 1812001, 22032961, 22114363, 23014570; 6496722/B15064967224/21081990, 22012631, 22012674, 22012712, 22022735, 22012715, 22022790, 22022814, 22022825, 22022858, 22032880, 22032882, 22043126, 22043146, 22043168, 22053339, 22053358, 22053248, 23014630, 23034993, 23035018, 23035017, 23045235; 6496723/B15064967234/22032892, 22032931, 22043213, 22114309, 22114358, 23034943; 1030/B15010304/22032995, 23014586; 51638/B150516384/22033023, 23014632; 52333/B150523334/22033017; 1010/B15010104/22063386, 22063498, 22073735, 23014593

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