Class 2 Device Recall Sterile Procedural Trays

• Date Initiated by Firm: November 17, 2022
• Date Posted: February 06, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1088-2023
• Recall Event ID: 91386
• Product Classification: Neurological tray - Product Code OJG
• Product: Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-LF h. NEURO PACK-LF i. NEURO PACK-LF j. NEURO PACK-LF k. NEURO/LAMINECTOMY BASIN PK-LF l. U H S NEURO PACK SC m. NEURO PACK-CELEBRATION n. NEURO PACK o. NEURO BASIN PACK-LF p. NEURO PACK q. MAJOR NEURO PK-LF r. NINOR NEURO PK-LF s. NEURO VP SHUNT/VAGAL NERVE-RF t. NEURO PACK-LF u. NEURO PACK v. CRANIOTOMY w. PEDIATRIC NEURO PACK x. NEURO MATRIX PACK y. ACOUSTIC NEUROMA PACK-LF z. MAJOR NEURO PACK-LF aa. SCRIPPS SW NEURO PACK-LF bb. NEURO PACK cc. GENERAL PACK dd. NEURO PK ee. NEURO PACK ff. NEURO PACK gg. NEURO PACK hh. NEURO PACK-LF ii. NEURO PACK jj. NEURO PACK kk. NEURO PACK ll. NEURO PACK mm. CRANIOTOMY PACK nn. PK, NEURO-MINOR oo. NEURO PACK pp. NEURO PACK qq. NEURO PACK rr. PK, NEURO-MINOR ss. NEURO BASIC tt. NEURO BASIC uu. CRANIOTOMY PACK (CRSJE)227-LF vv. NEURO PACK ww. NEURO PACK xx. NEURO CRANI PACK yy. NEURO PACK zz. NEURO TRAY-LF aaa. NEURO PACK bbb. WH NEURO PACK ccc. RFT ISC-N NEURO PACK ddd. NEURO-LF eee. NEURO PACK fff. NEURO LUMBAR PACK ggg. NEURO FUSION PACK-LF hhh. NEURO CERVICAL PACK iii. NEURO PACK jjj. VP SHUNT PACK kkk. NEURO BASIC PACK lll. NEURO PACK mmm. CHRISTUS CHILDRENS NEURO PK nnn. CHRISTUS CHILDRENS VP SHUNT PK ooo. RF NEURO-SHUNT PACK ppp. NEURO PACK qqq. NEURO PACK rrr. NEURO ST DAVIDS MEDICAL CTR sss. GIO NEURO PACK ttt. NEURO KIT uuu. DISCECTOMY PACK vvv. NEURO PACK www. BASIC NEURO PACK-LF xxx. NEURO PACK yyy. NEURO PACK zzz. NEURO aaaa. NEURO bbbb. FHCW NEURO PACK cccc. NEURO FERREE dddd. NEURO eeee. NEURO PACK CW ffff. NEURO gggg. FHT NEURO hhhh. NEURO BASIC iiii. NEURO LUMBAR jjjj. NCH NEURO kkkk. TAVI llll. CHN OR NEURO mmmm. NEURO PACK-LF nnnn. NEURO-CRANI-LF
• Code Information: a. AV SHUNT CDS, Item Number: CDS983098D, Case UDI/GTIN: 40195327191307, Unit UDI/GTIN: 10195327191306, Lot Number: 22IBD957; b. ZALE V-P SHUNT CDS, Item Number: CDS983186J, Case UDI/GTIN: 40195327105625, Unit UDI/GTIN: 10195327105624, Lot Number: 22IBT194; c. NEURO CDS-LF, Item Number: CDS985289, Case UDI/GTIN: 40888277050502, Unit UDI/GTIN: 10888277050501, Lot Number: 22JBH363,22IBF823,22IBD861; d. MAJOR NEURO, Item Number: CDS985548N, Case UDI/GTIN: 40195327033256, Unit UDI/GTIN: 10195327033255, Lot Number: 22JBR391,22JBI641,22GBG964; e. NEURO PACK-LF, Item Number: DYNJ0038440B, Case UDI/GTIN: 40193489506885, Unit UDI/GTIN: 10193489506884, Lot Number: 22IME936; f. CUSTOM NEURO PACK-LF, Item Number: DYNJ0190156F, Case UDI/GTIN: 40193489357531, Unit UDI/GTIN: 10193489357530, Lot Number: 22JMA809; g. NEURO PACK-LF, Item Number: DYNJ0367094L, Case UDI/GTIN: 40889942123859, Unit UDI/GTIN: 10889942123858, Lot Number: 22IMI193,22HMF079; h. NEURO PACK-LF, Item Number: DYNJ0374024J, Case UDI/GTIN: 40889942902119, Unit UDI/GTIN: 10889942902118, Lot Number: 22HBW509,22HBX254,22HBV379; i. NEURO PACK-LF, Item Number: DYNJ04596K, Case UDI/GTIN: 40193489301343, Unit UDI/GTIN: 10193489301342, Lot Number: 22JMA062,22IMB264; j. NEURO PACK-LF, Item Number: DYNJ04671Q, Case UDI/GTIN: 40888277743312, Unit UDI/GTIN: 10888277743311, Lot Number: 22HMC512; k. NEURO/LAMINECTOMY BASIN PK-LF, Item Number: DYNJ0781823K, Case UDI/GTIN: 40193489919197, Unit UDI/GTIN: 10193489919196, Lot Number: 22JMB723,22HMD049; l. U H S NEURO PACK SC, Item Number: DYNJ07952J, Case UDI/GTIN: 40889942607953, Unit UDI/GTIN: 10889942607952, Lot Number: 22JBO711; m. NEURO PACK-CELEBRATION, Item Number: DYNJ14032, Case UDI/GTIN: 40080196777953, Unit UDI/GTIN: 10080196777952, Lot Number: 22KBB459,22IBU513; n. NEURO PACK, Item Number: DYNJ14077I, Case UDI/GTIN: 40193489927673, Unit UDI/GTIN: 10193489927672, Lot Number: 22JBJ480; o. NEURO BASIN PACK-LF, Item Number: DYNJ16473K, Case UDI/GTIN: 40193489920865, Unit UDI/GTIN: 10193489920864, Lot Number: 22JDC136,22HDC097; p. NEURO PACK, Item Number: DYNJ19847M, Case UDI/GTIN: 40888277792303, Unit UDI/GTIN: 10888277792302, Lot Number: 22JBY146,22JBK343; q. MAJOR NEURO PK-LF, Item Number: DYNJ21243M, Case UDI/GTIN: 40193489225236, Unit UDI/GTIN: 10193489225235, Lot Number: 22HBY346; r. NINOR NEURO PK-LF, Item Number: DYNJ21244N, Case UDI/GTIN: 40193489225229, Unit UDI/GTIN: 10193489225228, Lot Number: 22JBV649; s. NEURO VP SHUNT/VAGAL NERVE-RF, Item Number: DYNJ21925S, Case UDI/GTIN: 40195327105021, Unit UDI/GTIN: 10195327105020, Lot Number: 22IBS173; t. NEURO PACK-LF, Item Number: DYNJ25097F, Case UDI/GTIN: 40889942871576, Unit UDI/GTIN: 10889942871575, Lot Number: 22JBK228,22JBI289; u. NEURO PACK, Item Number: DYNJ30477K, Case UDI/GTIN: 40193489912679, Unit UDI/GTIN: 10193489912678, Lot Number: 22JMG210,22HMB824; v. CRANIOTOMY, Item Number: DYNJ35349C, Case UDI/GTIN: 40888277858061, Unit UDI/GTIN: 10888277858060, Lot Number: 22HBP277; w. PEDIATRIC NEURO PACK, Item Number: DYNJ35480F, Case UDI/GTIN: 40193489803694, Unit UDI/GTIN: 10193489803693, Lot Number: 22JMB626,22IMF848,22IMC064; x. NEURO MATRIX PACK, Item Number: DYNJ36594F, Case UDI/GTIN: 40193489928991, Unit UDI/GTIN: 10193489928990, Lot Number: 22JBF140,22IBG656,22HBM006; y. ACOUSTIC NEUROMA PACK-LF, Item Number: DYNJ37741B, Case UDI/GTIN: 40195327081332, Unit UDI/GTIN: 10195327081331, Lot Number: 22JMC172,22HMD563; z. MAJOR NEURO PACK-LF, Item Number: DYNJ37751B, Case UDI/GTIN: 40195327082209, Unit UDI/GTIN: 10195327082208, Lot Number: 22JMF991; aa. SCRIPPS SW NEURO PACK-LF, Item Number: DYNJ39836F, Case UDI/GTIN: 40195327176717, Unit UDI/GTIN: 10195327176716, Lot Number: 22JME760,22HMI113,22HMD278,22GMB860; bb. NEURO PACK, Item Number: DYNJ41225B, Case UDI/GTIN: 40193489675673, Unit UDI/GTIN: 10193489675672, Lot Number: 22JBX284; cc. GENERAL PACK, Item Number: DYNJ41249C, Case UDI/GTIN: 40888277882035, Unit UDI/GTIN: 10888277882034, Lot Number: 22IBG204; dd. NEURO PK, Item Number: DYNJ41276F, Case UDI/GTIN: 40195327204021, Unit UDI/GTIN: 10195327204020, Lot Number: 22JMG029,22HMD792; ee. NEURO PACK, Item Number: DYNJ41579A, Case UDI/GTIN: 40888277935274, Unit UDI/GTIN: 10888277935273, Lot Number: 22IBA883; ff. NEURO PACK, Item Number: DYNJ41633B, Case UDI/GTIN: 40888277934918, Unit UDI/GTIN: 10888277934917, Lot Number: 22IBU441,22HBX309,22HBP962; gg. NEURO PACK, Item Number: DYNJ42484, Case UDI/GTIN: 40884389924045, Unit UDI/GTIN: 10884389924044, Lot Number: 22IBH224; hh. NEURO PACK-LF, Item Number: DYNJ42844D, Case UDI/GTIN: 40193489880565, Unit UDI/GTIN: 10193489880564, Lot Number: 22JBT933,22HBZ336; ii. NEURO PACK, Item Number: DYNJ43177B, Case UDI/GTIN: 40889942884392, Unit UDI/GTIN: 10889942884391, Lot Number: 22IMC154; jj. NEURO PACK, Item Number: DYNJ43856C, Case UDI/GTIN: 40195327200238, Unit UDI/GTIN: 10195327200237, Lot Number: 22IBS432,22HBP196; kk. NEURO PACK, Item Number: DYNJ43934A, Case UDI/GTIN: 40193489733601, Unit UDI/GTIN: 10193489733600, Lot Number: 22IMD151; ll. NEURO PACK, Item Number: DYNJ44014B, Case UDI/GTIN: 40889942278917, Unit UDI/GTIN: 10889942278916, Lot Number: 22KMA329,22JMC591; mm. CRANIOTOMY PACK, Item Number: DYNJ44040, Case UDI/GTIN: 40888277085955, Unit UDI/GTIN: 10888277085954, Lot Number: 22HBV694; nn. PK, NEURO-MINOR, Item Number: DYNJ45053C, Case UDI/GTIN: 40195327248759, Unit UDI/GTIN: 10195327248758, Lot Number: 22IBT923; oo. NEURO PACK, Item Number: DYNJ45267B, Case UDI/GTIN: 40193489852425, Unit UDI/GTIN: 10193489852424, Lot Number: 22HBV288; pp. NEURO PACK, Item Number: DYNJ46232A, Case UDI/GTIN: 40889942153450, Unit UDI/GTIN: 10889942153459, Lot Number: 22JBW760; qq. NEURO PACK, Item Number: DYNJ46238C, Case UDI/GTIN: 40888277737304, Unit UDI/GTIN: 10888277737303, Lot Number: 22IBG653,22HBX977,22HBX980; rr. PK, NEURO-MINOR, Item Number: DYNJ46282A, Case UDI/GTIN: 40193489310475, Unit UDI/GTIN: 10193489310474, Lot Number: 22JBO162,22JBO223,22IBJ968; ss. NEURO BASIC, Item Number: DYNJ46424D, Case UDI/GTIN: 40193489710350, Unit UDI/GTIN: 10193489710359, Lot Number: 22IBD742; tt. NEURO BASIC, Item Number: DYNJ46424F, Case UDI/GTIN: 40195327260683, Unit UDI/GTIN: 10195327260682, Lot Number: 22JBB084; uu. CRANIOTOMY PACK (CRSJE)227-LF, Item Number: DYNJ47487A, Case UDI/GTIN: 40889942106241, Unit UDI/GTIN: 10889942106240, Lot Number: 22JMF056,22HMD080; vv. NEURO PACK, Item Number: DYNJ48765, Case UDI/GTIN: 40888277943491, Unit UDI/GTIN: 10888277943490, Lot Number: 22IBQ098,22IBE948,22HME671; ww. NEURO PACK, Item Number: DYNJ49004, Case UDI/GTIN: 40888277810809, Unit UDI/GTIN: 10888277810808, Lot Number: 22JMI090,22JMC180,22IMD860,22HMD361; xx. NEURO CRANI PACK, Item Number: DYNJ49358, Case UDI/GTIN: 40888277847096, Unit UDI/GTIN: 10888277847095, Lot Number: 22JBQ325; yy. NEURO PACK, Item Number: DYNJ49529B, Case UDI/GTIN: 40889942203780, Unit UDI/GTIN: 10889942203789, Lot Number: 22IBS439,22IBE973; zz. NEURO TRAY-LF, Item Number: DYNJ49580C, Case UDI/GTIN: 40193489231206, Unit UDI/GTIN: 10193489231205, Lot Number: 22IBN986; aaa. NEURO PACK, Item Number: DYNJ50292F, Case UDI/GTIN: 40193489834438, Unit UDI/GTIN: 10193489834437, Lot Number: 22JBV778,22JBC215; bbb. WH NEURO PACK, Item Number: DYNJ50569, Case UDI/GTIN: 40889942008453, Unit UDI/GTIN: 10889942008452, Lot Number: 22JBQ343; ccc. RFT ISC-N NEURO PACK, Item Number: DYNJ50852G, Case UDI/GTIN: 40193489565028, Unit UDI/GTIN: 10193489565027, Lot Number: 22JMA472,22HMD933; ddd. NEURO-LF, Item Number: DYNJ52055F, Case UDI/GTIN: 40195327096336, Unit UDI/GTIN: 10195327096335, Lot Number: 22IBD221; eee. NEURO PACK, Item Number: DYNJ52243B, Case UDI/GTIN: 40889942829294, Unit UDI/GTIN: 10889942829293, Lot Number: 22IMF259; fff. NEURO LUMBAR PACK, Item Number: DYNJ53664D, Case UDI/GTIN: 40193489232067, Unit UDI/GTIN: 10193489232066, Lot Number: 22IBH772; ggg. NEURO FUSION PACK-LF, Item Number: DYNJ54360C, Case UDI/GTIN: 40193489815451, Unit UDI/GTIN: 10193489815450, Lot Number: 22IBR798; hhh. NEURO CERVICAL PACK, Item Number: DYNJ55737A, Case UDI/GTIN: 40889942943266, Unit UDI/GTIN: 10889942943265, Lot Number: 22JMB645; iii. NEURO PACK, Item Number: DYNJ57663, Case UDI/GTIN: 40889942763840, Unit UDI/GTIN: 10889942763849, Lot Number: 22JBW468,22IBB120; jjj. VP SHUNT PACK, Item Number: DYNJ59702F, Case UDI/GTIN: 40195327200269, Unit UDI/GTIN: 10195327200268, Lot Number: 22JBM510; kkk. NEURO BASIC PACK, Item Number: DYNJ60054, Case UDI/GTIN: 40888277797988, Unit UDI/GTIN: 10888277797987, Lot Number: 22KBA488,22JBR179,22IBI219; lll. NEURO PACK, Item Number: DYNJ60792C, Case UDI/GTIN: 40195327126965, Unit UDI/GTIN: 10195327126964, Lot Number: 22HBN525; mmm. CHRISTUS CHILDRENS NEURO PK, Item Number: DYNJ61168B, Case UDI/GTIN: 40195327118946, Unit UDI/GTIN: 10195327118945, Lot Number: 22IBR244,22HBY116,22HBV048; nnn. CHRISTUS CHILDRENS VP SHUNT PK, Item Number: DYNJ61174B, Case UDI/GTIN: 40195327119486, Unit UDI/GTIN: 10195327119485, Lot Number: 22JLA318,22ILA429,22HLB020; ooo. RF NEURO-SHUNT PACK, Item Number: DYNJ61387A, Case UDI/GTIN: 40193489444149, Unit UDI/GTIN: 10193489444148, Lot Number: 22IMG094,22IMG100; ppp. NEURO PACK, Item Number: DYNJ61419A, Case UDI/GTIN: 40193489676366, Unit UDI/GTIN: 10193489676365, Lot Number: 22JMH617; qqq. NEURO PACK, Item Number: DYNJ61740F, Case UDI/GTIN: 40195327238811, Unit UDI/GTIN: 10195327238810, Lot Number: 22IBF063; rrr. NEURO ST DAVIDS MEDICAL CTR, Item Number: DYNJ61998, Case UDI/GTIN: 40193489615013, Unit UDI/GTIN: 10193489615012, Lot Number: 22IBF340,22HBX978,22HBX979; sss. GIO NEURO PACK, Item Number: DYNJ62652A, Case UDI/GTIN: 40193489224581, Unit UDI/GTIN: 10193489224580, Lot Number: 22IBK347; ttt. NEURO KIT, Item Number: DYNJ62854C, Case UDI/GTIN: 40193489426985, Unit UDI/GTIN: 10193489426984, Lot Number: 22IBU624; uuu. DISCECTOMY PACK, Item Number: DYNJ67835, Case UDI/GTIN: 40193489444811, Unit UDI/GTIN: 10193489444810, Lot Number: 22IBV281; vvv. NEURO PACK, Item Number: DYNJ68898C, Case UDI/GTIN: 40195327060283, Unit UDI/GTIN: 10195327060282, Lot Number: 22IMI313; www. BASIC NEURO PACK-LF, Item Number: DYNJ81867, Case UDI/GTIN: 40195327153305, Unit UDI/GTIN: 10195327153304, Lot Number: 22HMC380,22HMB884; xxx. NEURO PACK, Item Number: DYNJ82633, Case UDI/GTIN: 40195327199556, Unit UDI/GTIN: 10195327199555, Lot Number: 22HBM512; yyy. NEURO PACK, Item Number: DYNJ83029, Case UDI/GTIN: 40195327228980, Unit UDI/GTIN: 10195327228989, Lot Number: 22JBV413; zzz. NEURO, Item Number: DYNJ900904J, Case UDI/GTIN: 40193489906616, Unit UDI/GTIN: 10193489906615, Lot Number: 22JBY355,22KBC323; aaaa. NEURO, Item Number: DYNJ901680G, Case UDI/GTIN: 40193489308083, Unit UDI/GTIN: 10193489308082, Lot Number: 22KBA252,22JBE473; bbbb. FHCW NEURO PACK, Item Number: DYNJ901990C, Case UDI/GTIN: 40193489932363, Unit UDI/GTIN: 10193489932362, Lot Number: 22JBL441,22IBV599; cccc. NEURO FERREE, Item Number: DYNJ902388K, Case UDI/GTIN: 40195327224753, Unit UDI/GTIN: 10195327224752, Lot Number: 22IBS547; dddd. NEURO, Item Number: DYNJ902585A, Case UDI/GTIN: 40193489985413, Unit UDI/GTIN: 10193489985412, Lot Number: 22IDA639; eeee. NEURO PACK CW, Item Number: DYNJ903091B, Case UDI/GTIN: 40193489961530, Unit UDI/GTIN: 10193489961539, Lot Number: 22IBU575,22IBU579; ffff. NEURO, Item Number: DYNJ903519A, Case UDI/GTIN: 40889942594215, Unit UDI/GTIN: 10889942594214, Lot Number: 22JBU552; gggg. FHT NEURO, Item Number: DYNJ903566C, Case UDI/GTIN: 40193489932103, Unit UDI/GTIN: 10193489932102, Lot Number: 22JBB451; hhhh. NEURO BASIC, Item Number: DYNJ904052G, Case UDI/GTIN: 40195327220922, Unit UDI/GTIN: 10195327220921, Lot Number: 22KDA580,22KDA234; iiii. NEURO LUMBAR, Item Number: DYNJ904111I, Case UDI/GTIN: 40193489363518, Unit UDI/GTIN: 10193489363517, Lot Number: 22IBO732,22IBN438,22IBA887; jjjj. NCH NEURO, Item Number: DYNJ904797B, Case UDI/GTIN: 40195327037988, Unit UDI/GTIN: 10195327037987, Lot Number: 22IBF188; kkkk. TAVI, Item Number: DYNJ904981C, Case UDI/GTIN: 40193489475136, Unit UDI/GTIN: 10193489475135, Lot Number: 22JBV630,22JBB134; llll. CHN OR NEURO, Item Number: DYNJ907876A, Case UDI/GTIN: 40195327011117, Unit UDI/GTIN: 10195327011116, Lot Number: 22HBR766; mmmm. NEURO PACK-LF, Item Number: DYNJC9302F, Case UDI/GTIN: 40195327032754, Unit UDI/GTIN: 10195327032753, Lot Number: 22JMB483; nnnn. NEURO-CRANI-LF, Item Number: DYNJS1001A, Case UDI/GTIN: 40080196665373, Unit UDI/GTIN: 10080196665372, Lot Number: 22IBS931,22HBX420
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 886-359-1704
• Manufacturer Reason for Recall: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
• FDA Determined Cause: Device Design
• Action: Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.
• Quantity in Commerce: 6,782 cases (15,253 units)
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.