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Sterile Procedural Trays, labeled as the following recallZ-1088-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 17, 2022

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 MEDLINE INDUSTRIES, LP - Northfield 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

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1088-2023
Status
Open, Classified
Initiated by the company
Nov 17, 2022
Posted by the FDA
Feb 6, 2023
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
6,782 cases (15,253 units)
Product code
OJG
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

Product description

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 (models, lots, serial numbers)

Show the full code information (13k characters)

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

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 91386).

Sources and updates

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