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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-2165-2023
Recall Event ID 92466
Product Classification Cardiovascular procedure kit - Product Code OEZ
Product Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A; b) EP PROCEDURE PACK, Model Number DYNJ67771; c) EP PACK, Model Number DYNJ68019; d) GWINNETT ENDOVASCULAR WSTE MGT, Model Number DYNJ68198; e) TAVR PACK, Model Number DYNJ68499B; f) VEIN CLINIC, Model Number DYNJ68667; g) VASCULAR PACK, Model Number DYNJ68863; h) VASCULAR PACK, Model Number DYNJ68880; i) TAVR PACK, Model Number DYNJ68933; j) PROCEDURE PACK, Model Number DYNJ68968A; k) PORT PACK, Model Number DYNJ68990A; l) STROKE PACK, Model Number DYNJ69009A; m) ENDOVENOUS BASIC PACK, Model Number DYNJ69108A; n) VEIN ABLATION KIT, Model Number DYNJ69272A; o) UPPER ENDOVASCULAR PK, Model Number DYNJ69302; p) STROKE PACK, Model Number DYNJ69422; q) UNM PREHOSPITAL ECMO PACK, Model Number DYNJ69622; r) UNM ACCESS PACK, Model Number DYNJ69624; s) FLUSHING VASCULAR CENTER, Model Number DYNJ69626; t) AFIB PACK, Model Number DYNJ69682; u) ENDOVASCULAR PACK, Model Number DYNJ69691A; v) FISTULA SAVANNAH PACK, Model Number DYNJ69943A; w) VEIN PACK, Model Number DYNJ80199A; x) VEIN PACK, Model Number DYNJ80199B; y) VASCULAR PACK, Model Number DYNJ80310; z) CAROTID PACK, Model Number DYNJ80346A; aa) ENDOVENOUS ABLATION PACK, Model Number DYNJ80489; bb) STROKE KIT, Model Number DYNJ80506; cc) VEIN PACK, Model Number DYNJ80868; dd) VASCULAR ACCESS PACK, Model Number DYNJ81022; ee) VASCULAR GENERAL PACK, Model Number DYNJ81023; ff) AV FISTULA PACK, Model Number DYNJ81033; gg) TAVR PACK, Model Number DYNJ81095; hh) VASCULAR INSTITUTE OF KS PACK, Model Number DYNJ81200; ii) VASCULAR INSTITUTE OF KS PACK, Model Number DYNJ81200A; jj) LINQ PACK, Model Number DYNJ81320; kk) EP DRAPE, Model Number DYNJ81462A; ll) OR VASCULAR ANGIO PACK, Model Number DYNJ81592A; mm) OR VASCULAR ANGIO PACK, Model Number DYNJ81592B; nn) AV FISTULA PACK, Model Number DYNJ81605; oo) MAJOR VASCULAR PACK, Model Number DYNJ81610; pp) MAJOR VASCULAR PACK, Model Number DYNJ81610A; qq) MAJOR VASCULAR PACK, Model Number DYNJ81610B; rr) PROCEDURE PACK, Model Number DYNJ81618; ss) VASCULAR PACK, Model Number DYNJ81626; tt) VASCULAR PACK, Model Number DYNJ81626A; uu) VASCULAR KIT, Model Number DYNJ81642; vv) VASCULAR KIT, Model Number DYNJ81642A; ww) USGS PACK, Model Number DYNJ81705; xx) EP PACK, Model Number DYNJ81716; yy) EP PACK, Model Number DYNJ81716A; zz) EP PACK, Model Number DYNJ81716B; aaa) VASCULAR PACK, Model Number DYNJ82104; bbb) VASCULAR AND INTERVENTION, Model Number DYNJ82109; ccc) VASCULAR PACK, Model Number DYNJ82144; ddd) SPECIALS MINOR RADIOLOGY PACK, Model Number DYNJ82314; eee) TAVR PACK, Model Number DYNJ82372; fff) FISTULA PACK, Model Number DYNJ82711; ggg) IR ANGIOGRAM LIGHT PK, Model Number DYNJ82858A; hhh) IR ANGIOGRAM PACK, Model Number DYNJ82859A; iii) MARGIN SIMPLE VEIN PACK, Model Number DYNJ82987; jjj) MARGIN FULL VEIN PACK, Model Number DYNJ82988; kkk) MARGIN FULL VEIN PACK, Model Number DYNJ82988A; lll) ARTERIOGRAM PACK 2, Model Number DYNJ83051; mmm) VASCULAR PACK, Model Number DYNJ83146; nnn) VEIN PACK, Model Number DYNJ83147; ooo) ENDOVASCULAR PACK, Model Number DYNJ83161; ppp) CVOR ANGIOGRAPHY PACK, Model Number DYNJ83432; qqq) VIRC STROKE PACK, Model Number DYNJ83461; rrr) RADIO VEIN ABLATION PACK, Model Number DYNJ83490; sss) ENDOVENOUS PACK, Model Number DYNJ83606; ttt) ENDO VASCULAR PACK, Model Number DYNJ83624; uuu) ENDOVASCULAR PACK, Model Number DYNJ83972; vvv) TEMP PERM KIT, Model Number DYNJ84130; www) VASCULAR PACK, Model Number DYNJ84252; xxx) OPEN HEART PART 2, Model Number DYNJ901075O; yyy) OPEN HEART PART 2, Model Number DYNJ901075P; zzz) CAROTID-LF, Model Number DYNJ901745K; aaaa) VASCULAR ANGIO, Model Number DYNJ902259B; bbbb) VASCULAR CUT DOWN, Model Number DYNJ902261G; cccc) VASCULAR, Model Number DYNJ902704P; dddd) ENDOVASCULAR, Model Number DYNJ903451D; eeee) TICKER FIXER2, Model Number DYNJ903919J; ffff) TICK
Code Information all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Numbers DYNJ67770A, UDI/DI (EA)10195327290979, UDI/DI (CS)40195327290970; b) Model Numbers DYNJ67771, UDI/DI (EA)10193489430721, UDI/DI (CS)40193489430722; c) Model Numbers DYNJ68019, UDI/DI (EA)10193489467840, UDI/DI (CS)40193489467841; d) Model Numbers DYNJ68198, UDI/DI (EA)10193489499179, UDI/DI (CS)40193489499170; e) Model Numbers DYNJ68499B, UDI/DI (EA)10195327034054, UDI/DI (CS)40195327034055; f) Model Numbers DYNJ68667, UDI/DI (EA)10193489837315, UDI/DI (CS)40193489837316; g) Model Numbers DYNJ68863, UDI/DI (EA)10193489845402, UDI/DI (CS)40193489845403; h) Model Numbers DYNJ68880, UDI/DI (EA)10193489847727, UDI/DI (CS)40193489847728; i) Model Numbers DYNJ68933, UDI/DI (EA)10193489860375, UDI/DI (CS)40193489860376; j) Model Numbers DYNJ68968A, UDI/DI (EA)10195327206840, UDI/DI (CS)40195327206841; k) Model Numbers DYNJ68990A, UDI/DI (EA)10193489981360, UDI/DI (CS)40193489981361; l) Model Numbers DYNJ69009A, UDI/DI (EA)10195327075569, UDI/DI (CS)40195327075560; m) Model Numbers DYNJ69108A, UDI/DI (EA)10195327025717, UDI/DI (CS)40195327025718; n) Model Numbers DYNJ69272A, UDI/DI (EA)10195327015800, UDI/DI (CS)40195327015801; o) Model Numbers DYNJ69302, UDI/DI (EA)10193489926279, UDI/DI (CS)40193489926270; p) Model Numbers DYNJ69422, UDI/DI (EA)10193489937541, UDI/DI (CS)40193489937542; q) Model Numbers DYNJ69622, UDI/DI (EA)10193489959581, UDI/DI (CS)40193489959582; r) Model Numbers DYNJ69624, UDI/DI (EA)10193489959567, UDI/DI (CS)40193489959568; s) Model Numbers DYNJ69626, UDI/DI (EA)10193489960693, UDI/DI (CS)40193489960694; t) Model Numbers DYNJ69682, UDI/DI (EA)10193489968927, UDI/DI (CS)40193489968928; u) Model Numbers DYNJ69691A, UDI/DI (EA)10195327070267, UDI/DI (CS)40195327070268; v) Model Numbers DYNJ69943A, UDI/DI (EA)10195327284633, UDI/DI (CS)40195327284634; w) Model Numbers DYNJ80199A, UDI/DI (EA)10195327040864, UDI/DI (CS)40195327040865; x) Model Numbers DYNJ80199B, UDI/DI (EA)10195327088200, UDI/DI (CS)40195327088201; y) Model Numbers DYNJ80310, UDI/DI (EA)10195327023201, UDI/DI (CS)40195327023202; z) Model Numbers DYNJ80346A, UDI/DI (EA)10195327166250, UDI/DI (CS)40195327166251; aa) Model Numbers DYNJ80489, UDI/DI (EA)10195327045845, UDI/DI (CS)40195327045846; bb) Model Numbers DYNJ80506, UDI/DI (EA)10195327049171, UDI/DI (CS)40195327049172; cc) Model Numbers DYNJ80868, UDI/DI (EA)10195327082505, UDI/DI (CS)40195327082506; dd) Model Numbers DYNJ81022, UDI/DI (EA)10195327082789, UDI/DI (CS)40195327082780; ee) Model Numbers DYNJ81023, UDI/DI (EA)10195327082796, UDI/DI (CS)40195327082797; ff) Model Numbers DYNJ81033, UDI/DI (EA)10195327082987, UDI/DI (CS)40195327082988; gg) Model Numbers DYNJ81095, UDI/DI (EA)10195327084127, UDI/DI (CS)40195327084128; hh) Model Numbers DYNJ81200, UDI/DI (EA)10195327091699, UDI/DI (CS)40195327091690; ii) Model Numbers DYNJ81200A, UDI/DI (EA)10195327224714, UDI/DI (CS)40195327224715; jj) Model Numbers DYNJ81320, UDI/DI (EA)10195327110147, UDI/DI (CS)40195327110148; kk) Model Numbers DYNJ81462A, UDI/DI (EA)10195327378615, UDI/DI (CS)40195327378616; ll) Model Numbers DYNJ81592A, UDI/DI (EA)10195327315054, UDI/DI (CS)40195327315055; mm) Model Numbers DYNJ81592B, UDI/DI (EA)10195327398309, UDI/DI (CS)40195327398300; nn) Model Numbers DYNJ81605, UDI/DI (EA)10195327123888, UDI/DI (CS)40195327123889; oo) Model Numbers DYNJ81610, UDI/DI (EA)10195327123949, UDI/DI (CS)40195327123940; pp) Model Numbers DYNJ81610A, UDI/DI (EA)10195327315047, UDI/DI (CS)40195327315048; qq) Model Numbers DYNJ81610B, UDI/DI (EA)10195327398316, UDI/DI (CS)40195327398317; rr) Model Numbers DYNJ81618, UDI/DI (EA)10195327124601, UDI/DI (CS)40195327124602; ss) Model Numbers DYNJ81626, UDI/DI (EA)10195327127060, UDI/DI (CS)40195327127061; tt) Model Numbers DYNJ81626A, UDI/DI (EA)10195327297190, UDI/DI (CS)40195327297191; uu) Model Numbers DYNJ81642, UDI/DI (EA)10195327129668, UDI/DI (CS)40195327129669; vv) Model Numbers DYNJ81642A, UDI/DI (EA)10195327266387, UDI/DI (CS)40195327266388; ww) Model Numbers DYNJ81705, UDI/DI (EA)10195327135577, UDI/DI (CS)40195327135578; xx) Model Numbers DYNJ81716, UDI/DI (EA)10195327138066, UDI/DI (CS)40195327138067; yy) Model Numbers DYNJ81716A, UDI/DI (EA)10195327203856, UDI/DI (CS)40195327203857; zz) Model Numbers DYNJ81716B, UDI/DI (EA)10195327277260, UDI/DI (CS)40195327277261; aaa) Model Numbers DYNJ82104, UDI/DI (EA)10195327171087, UDI/DI (CS)40195327171088; bbb) Model Numbers DYNJ82109, UDI/DI (EA)10195327171247, UDI/DI (CS)40195327171248; ccc) Model Numbers DYNJ82144, UDI/DI (EA)10195327178031, UDI/DI (CS)40195327178032; ddd) Model Numbers DYNJ82314, UDI/DI (EA)10195327184216, UDI/DI (CS)40195327184217; eee) Model Numbers DYNJ82372, UDI/DI (EA)10195327187538, UDI/DI (CS)40195327187539; fff) Model Numbers DYNJ82711, UDI/DI (EA)10195327203627, UDI/DI (CS)40195327203628; ggg) Model Numbers DYNJ82858A, UDI/DI (EA)10195327244897, UDI/DI (CS)40195327244898; hhh) Model Numbers DYNJ82859A, UDI/DI (EA)10195327244903, UDI/DI (CS)40195327244904; iii) Model Numbers DYNJ82987, UDI/DI (EA)10195327222116, UDI/DI (CS)40195327222117; jjj) Model Numbers DYNJ82988, UDI/DI (EA)10195327222208, UDI/DI (CS)40195327222209; kkk) Model Numbers DYNJ82988A, UDI/DI (EA)10195327293314, UDI/DI (CS)40195327293315; lll) Model Numbers DYNJ83051, UDI/DI (EA)10195327245283, UDI/DI (CS)40195327245284; mmm) Model Numbers DYNJ83146, UDI/DI (EA)10195327235680, UDI/DI (CS)40195327235681; nnn) Model Numbers DYNJ83147, UDI/DI (EA)10195327235505, UDI/DI (CS)40195327235506; ooo) Model Numbers DYNJ83161, UDI/DI (EA)10195327237837, UDI/DI (CS)40195327237838; ppp) Model Numbers DYNJ83432, UDI/DI (EA)10195327266530, UDI/DI (CS)40195327266531; qqq) Model Numbers DYNJ83461, UDI/DI (EA)10195327267797, UDI/DI (CS)40195327267798; rrr) Model Numbers DYNJ83490, UDI/DI (EA)10195327271411, UDI/DI (CS)40195327271412; sss) Model Numbers DYNJ83606, UDI/DI (EA)10195327284855, UDI/DI (CS)40195327284856; ttt) Model Numbers DYNJ83624, UDI/DI (EA)10195327285869, UDI/DI (CS)40195327285860; uuu) Model Numbers DYNJ83972, UDI/DI (EA)10195327322694, UDI/DI (CS)40195327322695; vvv) Model Numbers DYNJ84130, UDI/DI (EA)10195327334550, UDI/DI (CS)40195327334551; www) Model Numbers DYNJ84252, UDI/DI (EA)10195327345570, UDI/DI (CS)40195327345571; xxx) Model Numbers DYNJ901075O, UDI/DI (EA)10195327052683, UDI/DI (CS)40195327052684; yyy) Model Numbers DYNJ901075P, UDI/DI (EA)10195327253554, UDI/DI (CS)40195327253555; zzz) Model Numbers DYNJ901745K, UDI/DI (EA)10193489482232, UDI/DI (CS)40193489482233; aaaa) Model Numbers DYNJ902259B, UDI/DI (EA)10193489919714, UDI/DI (CS)40193489919715; bbbb) Model Numbers DYNJ902261G, UDI/DI (EA)10193489919721, UDI/DI (CS)40193489919722; cccc) Model Numbers DYNJ902704P, UDI/DI (EA)10193489863376, UDI/DI (CS)40193489863377; dddd) Model Numbers DYNJ903451D, UDI/DI (EA)10193489667851, UDI/DI (CS)40193489667852; eeee) Model Numbers DYNJ903919J, UDI/DI (EA)10195327045906, UDI/DI (CS)40195327045907; ffff) Model Numbers DYNJ903919K, UDI/DI (EA)10195327218782, UDI/DI (CS)40195327218783; gggg) Model Numbers DYNJ903919L, UDI/DI (EA)10195327267056, UDI/DI (CS)40195327267057; hhhh) Model Numbers DYNJ904171F, UDI/DI (EA)10193489439243, UDI/DI (CS)40193489439244; iiii) Model Numbers DYNJ904401C, UDI/DI (EA)10193489348910, UDI/DI (CS)40193489348911; jjjj) Model Numbers DYNJ904984B, UDI/DI (EA)10193489812930, UDI/DI (CS)40193489812931; kkkk) Model Numbers DYNJ905079F, UDI/DI (EA)10195327209001, UDI/DI (CS)40195327209002; llll) Model Numbers DYNJ905285C, UDI/DI (EA)10193489947250, UDI/DI (CS)40193489947251; mmmm) Model Numbers DYNJ905291B, UDI/DI (EA)10193489950373, UDI/DI (CS)40193489950374; nnnn) Model Numbers DYNJ905291C, UDI/DI (EA)10195327062545, UDI/DI (CS)40195327062546; oooo) Model Numbers DYNJ905311I, UDI/DI (EA)10195327146214, UDI/DI (CS)40195327146215; pppp) Model Numbers DYNJ905516C, UDI/DI (EA)10193489967128, UDI/DI (CS)40193489967129; qqqq) Model Numbers DYNJ905516D, UDI/DI (EA)10195327147839, UDI/DI (CS)40195327147830; rrrr) Model Numbers DYNJ905516F, UDI/DI (EA)10195327247577, UDI/DI (CS)40195327247578; ssss) Model Numbers DYNJ905726C, UDI/DI (EA)10193489943375, UDI/DI (CS)40193489943376; tttt) Model Numbers DYNJ905726D, UDI/DI (EA)10195327161514, UDI/DI (CS)40195327161515; uuuu) Model Numbers DYNJ905744C, UDI/DI (EA)10195327162313, UDI/DI (CS)40195327162314; vvvv) Model Numbers DYNJ905859B, UDI/DI (EA)10193489417869, UDI/DI (CS)40193489417860; wwww) Model Numbers DYNJ905884A, UDI/DI (EA)10193489795448, UDI/DI (CS)40193489795449; xxxx) Model Numbers DYNJ906086B, UDI/DI (EA)10195327046354, UDI/DI (CS)40195327046355; yyyy) Model Numbers DYNJ906098A, UDI/DI (EA)10193489209457, UDI/DI (CS)40193489209458; zzzz) Model Numbers DYNJ906102F, UDI/DI (EA)10195327028268, UDI/DI (CS)40195327028269;
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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