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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Probe Cover Kits

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  Class 2 Device Recall Medline Probe Cover Kits see related information
Date Initiated by Firm May 18, 2023
Date Posted July 20, 2023
Recall Status1 Open3, Classified
Recall Number Z-2180-2023
Recall Event ID 92466
Product Classification General surgery tray - Product Code LRO
Product Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model Number DYNJ55954B; c) CLOT RETRIEVAL PACK, Model Number DYNJ56140B; d) VENOUS PACK, Model Number DYNJ56260B; e) WMC ULTRASOUND PACK, Model Number DYNJ56392; f) WMC ULTRASOUND PACK, Model Number DYNJ56392A; g) WMC ULTRASOUND PACK, Model Number DYNJ56392B; h) ULTRASOUND KIT-LF, Model Number DYNJ56507B; i) EVLT PACK, Model Number DYNJ56548B; j) RFA PACK, Model Number DYNJ57149; k) SPECIALS TRACE PACK, Model Number DYNJ57303B; l) CLOSURE PACK, Model Number DYNJ57514; m) EP PACK, Model Number DYNJ57594A; n) VEIN TRAY, Model Number DYNJ57736A; o) ENSEMBLE PICC LINE-LF, Model Number DYNJ57793; p) PICC LINE PACK-LF, Model Number DYNJ58160; q) ENDOVENOUS PACK, Model Number DYNJ58228; r) BIB AV FISTULA PACK, Model Number DYNJ58304; s) TRIPLE P KIT, Model Number DYNJ58424; t) LINQ TRAY, Model Number DYNJ58643A; u) TUBE CHANGE/SINOGRAM PACK, Model Number DYNJ59062; v) PICC PROCEDURE PACK, Model Number DYNJ59067; w) ENDOVASCULAR PACK, Model Number DYNJ59085; x) VEIN CLOSURE PACK, Model Number DYNJ59094; y) CLOSURE PROCEDURE, Model Number DYNJ59206; z) VNUS PACK, Model Number DYNJ59246; aa) DESERT CARDIOVASCULAR PACK, Model Number DYNJ59377; bb) EP LAB, Model Number DYNJ59392C; cc) VEIN PACK-LF, Model Number DYNJ59631; dd) PROCEDURE PACK, Model Number DYNJ59795A; ee) PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126A; ff) KF PACK, Model Number DYNJ60127A; gg) VENASEAL PACK, Model Number DYNJ60128A; hh) I.R. PACK, Model Number DYNJ60343A; ii) CLOSURE PACK, Model Number DYNJ60804; jj) CLOVIS MINOR IR PROCEDURE-LF, Model Number DYNJ61067; kk) CRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099A; ll) ECMO PACK, Model Number DYNJ61243; mm) VEIN PACK, Model Number DYNJ61264; nn) UNIVERSAL PACK, Model Number DYNJ61433; oo) OCEANA VEIN PROCEDURE PACK, Model Number DYNJ61517; pp) ENSEMBLE CHIMIO EMBOLISATION, Model Number DYNJ62295; qq) ENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295A; rr) ENS. CHIMIO EMBOLISATION-LF, Model Number DYNJ62295B; ss) SCLEROTHERAPY KIT, Model Number DYNJ62434A; tt) ABLATION PACK, Model Number DYNJ62540; uu) PROCEDURE PACK, Model Number DYNJ62588; vv) VEIN ABLATION, Model Number DYNJ63268B; ww) TF TAVR PACK, Model Number DYNJ63340; xx) AFCH DRUG INFUSION PUMP PA, Model Number DYNJ63354C; yy) ALL PURPOSE TRAY FOAKS, Model Number DYNJ63576A; zz) NIR PACK, Model Number DYNJ63892; aaa) ABLATION PACK, Model Number DYNJ64068; bbb) LASER KIT, Model Number DYNJ64075A; ccc) EVLT, Model Number DYNJ64336; ddd) PROCEDURE PACK, Model Number DYNJ64372A; eee) PREMIER PROCEDURE PACK, Model Number DYNJ64393; fff) MINOR SET UP PACK, Model Number DYNJ64439; ggg) VIP PACK, Model Number DYNJ64666A; hhh) CT ABLATION PACK, Model Number DYNJ64928A; iii) ULTRASOUND KIT, Model Number DYNJ64930; jjj) VEIN CLOSURE PACK, Model Number DYNJ65189C; kkk) PACK,LTD BODY SSP, Model Number DYNJ65488B; lll) EVLT PACK, Model Number DYNJ65995; mmm) EVLT PACK, Model Number DYNJ65995A; nnn) EVLT PACK, Model Number DYNJ66005; ooo) JVL-PACK TUNNELED, Model Number DYNJ66065; ppp) EVLA PACK, Model Number DYNJ66258; qqq) EVLA PACK, Model Number DYNJ66258A; rrr) ANGIOGRAM SET UP PACK, Model Number DYNJ66260; sss) IR PACKER, Model Number DYNJ66620A; ttt) CLOSURE PROCEDURE PACK, Model Number DYNJ66741; uuu) PHYSIATRY PACK, Model Number DYNJ67414; vvv) FEM POP PACK, Model Number DYNJ67487A; www) SPECIALS PACK, Model Number DYNJ67504A; xxx) SPECIALS PACK, Model Number DYNJ67504B; yyy) RFA PACK, Model Number DYNJ67899; zzz) RR-BRACHY PACK, Model Number DYNJ68027; aaaa) COPS PROCEDURE PACK-LF, Model Number DYNJ68923A; bbbb) PROCEDURE PACK, Model Number DYNJ68968; cccc) PORT PACK, Model Number DYNJ68990; dddd) ACCESS PACK, Model Number DYNJ69017; eeee) KF PACK 2.0, Model Number DYNJ69619; ffff) NLK BASIC PACK, Model Number DYNJ69716A; gg
Code Information all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ55841B, UDI/DI (EA) 10888277757684, UDI/DI (CS) 40888277757685; b) Model Number DYNJ55954B, UDI/DI (EA) 10193489214239, UDI/DI (CS) 40193489214230; c) Model Number DYNJ56140B, UDI/DI (EA) 10193489547672, UDI/DI (CS) 40193489547673; d) Model Number DYNJ56260B, UDI/DI (EA) 10193489569827, UDI/DI (CS) 40193489569828; e) Model Number DYNJ56392, UDI/DI (EA) 10889942640676, UDI/DI (CS) 40889942640677; f) Model Number DYNJ56392A, UDI/DI (EA) 10195327261405, UDI/DI (CS) 40195327261406; g) Model Number DYNJ56392B, UDI/DI (EA) 10195327323677, UDI/DI (CS) 40195327323678; h) Model Number DYNJ56507B, UDI/DI (EA) 10193489443479, UDI/DI (CS) 40193489443470; i) Model Number DYNJ56548B, UDI/DI (EA) 10193489813180, UDI/DI (CS) 40193489813181; j) Model Number DYNJ57149, UDI/DI (EA) 10889942721603, UDI/DI (CS) 40889942721604; k) Model Number DYNJ57303B, UDI/DI (EA) 10193489360646, UDI/DI (CS) 40193489360647; l) Model Number DYNJ57514, UDI/DI (EA) 10889942747849, UDI/DI (CS) 40889942747840; m) Model Number DYNJ57594A, UDI/DI (EA) 10889942963218, UDI/DI (CS) 40889942963219; n) Model Number DYNJ57736A, UDI/DI (EA) 10888277779709, UDI/DI (CS) 40888277779700; o) Model Number DYNJ57793, UDI/DI (EA) 10889942819164, UDI/DI (CS) 40889942819165; p) Model Number DYNJ58160, UDI/DI (EA) 10889942828647, UDI/DI (CS) 40889942828648; q) Model Number DYNJ58228, UDI/DI (EA) 10889942835492, UDI/DI (CS) 40889942835493; r) Model Number DYNJ58304, UDI/DI (EA) 10889942843732, UDI/DI (CS) 40889942843733; s) Model Number DYNJ58424, UDI/DI (EA) 10889942851836, UDI/DI (CS) 40889942851837; t) Model Number DYNJ58643A, UDI/DI (EA) 10193489809213, UDI/DI (CS) 40193489809214; u) Model Number DYNJ59062, UDI/DI (EA) 10889942941650, UDI/DI (CS) 40889942941651; v) Model Number DYNJ59067, UDI/DI (EA) 10889942930043, UDI/DI (CS) 40889942930044; w) Model Number DYNJ59085, UDI/DI (EA) 10889942932016, UDI/DI (CS) 40889942932017; x) Model Number DYNJ59094, UDI/DI (EA) 10889942933501, UDI/DI (CS) 40889942933502; y) Model Number DYNJ59206, UDI/DI (EA) 10888277765573, UDI/DI (CS) 40888277765574; z) Model Number DYNJ59246, UDI/DI (EA) 10888277767294, UDI/DI (CS) 40888277767295; aa) Model Number DYNJ59377, UDI/DI (EA) 10888277736290, UDI/DI (CS) 40888277736291; bb) Model Number DYNJ59392C, UDI/DI (EA) 10193489282245, UDI/DI (CS) 40193489282246; cc) Model Number DYNJ59631, UDI/DI (EA) 10888277764026, UDI/DI (CS) 40888277764027; dd) Model Number DYNJ59795A, UDI/DI (EA) 10193489566987, UDI/DI (CS) 40193489566988; ee) Model Number DYNJ60126A, UDI/DI (EA) 10193489247084, UDI/DI (CS) 40193489247085; ff) Model Number DYNJ60127A, UDI/DI (EA) 10193489729047, UDI/DI (CS) 40193489729048; gg) Model Number DYNJ60128A, UDI/DI (EA) 10193489544510, UDI/DI (CS) 40193489544511; hh) Model Number DYNJ60343A, UDI/DI (EA) 10193489573831, UDI/DI (CS) 40193489573832; ii) Model Number DYNJ60804, UDI/DI (EA) 10193489532784, UDI/DI (CS) 40193489532785; jj) Model Number DYNJ61067, UDI/DI (EA) 10193489542226, UDI/DI (CS) 40193489542227; kk) Model Number DYNJ61099A, UDI/DI (EA) 10193489463965, UDI/DI (CS) 40193489463966; ll) Model Number DYNJ61243, UDI/DI (EA) 10193489550917, UDI/DI (CS) 40193489550918; mm) Model Number DYNJ61264, UDI/DI (EA) 10193489554472, UDI/DI (CS) 40193489554473; nn) Model Number DYNJ61433, UDI/DI (EA) 10193489565171, UDI/DI (CS) 40193489565172; oo) Model Number DYNJ61517, UDI/DI (EA) 10193489577570, UDI/DI (CS) 40193489577571; pp) Model Number DYNJ62295, UDI/DI (EA) 10193489641165, UDI/DI (CS) 40193489641166; qq) Model Number DYNJ62295A, UDI/DI (EA) 10193489845952, UDI/DI (CS) 40193489845953; rr) Model Number DYNJ62295B, UDI/DI (EA) 10195327209933, UDI/DI (CS) 40195327209934; ss) Model Number DYNJ62434A, UDI/DI (EA) 10193489366273, UDI/DI (CS) 40193489366274; tt) Model Number DYNJ62540, UDI/DI (EA) 10193489666472, UDI/DI (CS) 40193489666473; uu) Model Number DYNJ62588, UDI/DI (EA) 10193489669831, UDI/DI (CS) 40193489669832; vv) Model Number DYNJ63268B, UDI/DI (EA) 10193489305111, UDI/DI (CS) 40193489305112; ww) Model Number DYNJ63340, UDI/DI (EA) 10193489741162, UDI/DI (CS) 40193489741163; xx) Model Number DYNJ63354C, UDI/DI (EA) 10195327273255, UDI/DI (CS) 40195327273256; yy) Model Number DYNJ63576A, UDI/DI (EA) 10193489429251, UDI/DI (CS) 40193489429252; zz) Model Number DYNJ63892, UDI/DI (EA) 10193489771435, UDI/DI (CS) 40193489771436; aaa) Model Number DYNJ64068, UDI/DI (EA) 10193489783131, UDI/DI (CS) 40193489783132; bbb) Model Number DYNJ64075A, UDI/DI (EA) 10193489231328, UDI/DI (CS) 40193489231329; ccc) Model Number DYNJ64336, UDI/DI (EA) 10193489801873, UDI/DI (CS) 40193489801874; ddd) Model Number DYNJ64372A, UDI/DI (EA) 10193489884685, UDI/DI (CS) 40193489884686; eee) Model Number DYNJ64393, UDI/DI (EA) 10193489809633, UDI/DI (CS) 40193489809634; fff) Model Number DYNJ64439, UDI/DI (EA) 10193489200485, UDI/DI (CS) 40193489200486; ggg) Model Number DYNJ64666A, UDI/DI (EA) 10193489317268, UDI/DI (CS) 40193489317269; hhh) Model Number DYNJ64928A, UDI/DI (EA) 10195327329815, UDI/DI (CS) 40195327329816; iii) Model Number DYNJ64930, UDI/DI (EA) 10193489231687, UDI/DI (CS) 40193489231688; jjj) Model Number DYNJ65189C, UDI/DI (EA) 10195327072001, UDI/DI (CS) 40195327072002; kkk) Model Number DYNJ65488B, UDI/DI (EA) 10193489443646, UDI/DI (CS) 40193489443647; lll) Model Number DYNJ65995, UDI/DI (EA) 10193489311549, UDI/DI (CS) 40193489311540; mmm) Model Number DYNJ65995A, UDI/DI (EA) 10195327068127, UDI/DI (CS) 40195327068128; nnn) Model Number DYNJ66005, UDI/DI (EA) 10193489312546, UDI/DI (CS) 40193489312547; ooo) Model Number DYNJ66065, UDI/DI (EA) 10193489319187, UDI/DI (CS) 40193489319188; ppp) Model Number DYNJ66258, UDI/DI (EA) 10193489325478, UDI/DI (CS) 40193489325479; qqq) Model Number DYNJ66258A, UDI/DI (EA) 10195327194239, UDI/DI (CS) 40195327194230; rrr) Model Number DYNJ66260, UDI/DI (EA) 10193489325461, UDI/DI (CS) 40193489325462; sss) Model Number DYNJ66620A, UDI/DI (EA) 10193489914245, UDI/DI (CS) 40193489914246; ttt) Model Number DYNJ66741, UDI/DI (EA) 10193489374940, UDI/DI (CS) 40193489374941; uuu) Model Number DYNJ67414, UDI/DI (EA) 10193489964646, UDI/DI (CS) 40193489964647; vvv) Model Number DYNJ67487A, UDI/DI (EA) 10193489888997, UDI/DI (CS) 40193489888998; www) Model Number DYNJ67504A, UDI/DI (EA) 10195327009618, UDI/DI (CS) 40195327009619; xxx) Model Number DYNJ67504B, UDI/DI (EA) 10195327331023, UDI/DI (CS) 40195327331024; yyy) Model Number DYNJ67899, UDI/DI (EA) 10193489454499, UDI/DI (CS) 40193489454490; zzz) Model Number DYNJ68027, UDI/DI (EA) 10193489469158, UDI/DI (CS) 40193489469159; aaaa) Model Number DYNJ68923A, UDI/DI (EA) 10195327070793, UDI/DI (CS) 40195327070794; bbbb) Model Number DYNJ68968, UDI/DI (EA) 10193489870398, UDI/DI (CS) 40193489870399; cccc) Model Number DYNJ68990, UDI/DI (EA) 10193489872613, UDI/DI (CS) 40193489872614; dddd) Model Number DYNJ69017, UDI/DI (EA) 10193489878158, UDI/DI (CS) 40193489878159; eeee) Model Number DYNJ69619, UDI/DI (EA) 10193489959444, UDI/DI (CS) 40193489959445; ffff) Model Number DYNJ69716A, UDI/DI (EA) 10195327250577, UDI/DI (CS) 40195327250578; gggg) Model Number DYNJ69820, UDI/DI (EA) 10193489981438, UDI/DI (CS) 40193489981439; hhhh) Model Number DYNJ80299, UDI/DI (EA) 10195327021931, UDI/DI (CS) 40195327021932; iiii) Model Number DYNJ81343, UDI/DI (EA) 10195327113063, UDI/DI (CS) 40195327113064; jjjj) Model Number DYNJ83152, UDI/DI (EA) 10195327237080, UDI/DI (CS) 40195327237081; kkkk) Model Number DYNJ83524, UDI/DI (EA) 10195327273491, UDI/DI (CS) 40195327273492; llll) Model Number DYNJ83931, UDI/DI (EA) 10195327315351, UDI/DI (CS) 40195327315352; mmmm) Model Number DYNJ83976, UDI/DI (EA) 10195327323196, UDI/DI (CS) 40195327323197; nnnn) Model Number DYNJ84172, UDI/DI (EA) 10195327338909, UDI/DI (CS) 40195327338900; oooo) Model Number DYNJ901348D, UDI/DI (EA) 10193489594683, UDI/DI (CS) 40193489594684; pppp) Model Number DYNJ901392D, UDI/DI (EA) 10193489539516, UDI/DI (CS) 40193489539517; qqqq) Model Number DYNJ902168D, UDI/DI (EA) 10193489866155, UDI/DI (CS) 40193489866156; rrrr) Model Number DYNJ902281, UDI/DI (EA) 10888277981416, UDI/DI (CS) 40888277981417; ssss) Model Number DYNJ905002A, UDI/DI (EA) 10889942911653, UDI/DI (CS) 40889942911654; tttt) Model Number DYNJ905335, UDI/DI (EA) 10889942875894, UDI/DI (CS) 40889942875895; uuuu) Model Number DYNJ905651B, UDI/DI (EA) 10193489925067, UDI/DI (CS) 40193489925068; vvvv) Model Number DYNJ905936B, UDI/DI (EA) 10193489422818, UDI/DI (CS) 40193489422819; wwww) Model Number DYNJ908752, UDI/DI (EA) 10195327171360, UDI/DI (CS) 40195327171361; xxxx) Model Number DYNJRA0585, UDI/DI (EA) 10888277580695, UDI/DI (CS) 40888277580696; yyyy) Model Number DYNJRA1155B, UDI/DI (EA) 10193489583717, UDI/DI (CS) 40193489583718; zzzz) Model Number DYNJRA1578, UDI/DI (EA) 10193489272789, UDI/DI (CS) 40193489272780;
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		 Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
FDA Determined
Cause 2		 Device Design
Action Medline distributed their recall notices to their consignees beginning on 05/18/2023 by letter. The notices explained the problem, and the risk and requested the destruction of the products. Distributors were directed to notify their consignees, have the customers document and destroy any affected product, and include your customers quantities on the response form. Beginning on 05/23/2023, Medline issued another notice to a separate group of consignees requesting that the kits be over labeled. Distributors were directed to notify the customers and have them return any affected product to the distributor for collection and return to Medline. Questions: please contact the Recall Department at 866-359-1704
Quantity in Commerce # included in 3,740,814 units total
Distribution Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
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.
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