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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-2161-2023
Recall Event ID 92466
Product Classification Cardiac catheterization kit - Product Code OES
Product Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) CATH LAB PACK, Model Number DYNJ55455A; c) CATH LAB 2, Model Number DYNJ55680A; d) IR ANGIO TRAY, Model Number DYNJ56038A; e) CATH PACK, Model Number DYNJ56547C; f) HYBRID, Model Number DYNJ57049G; g) HYBRID, Model Number DYNJ57049I; h) HYBRID, Model Number DYNJ57049J; i) PERCUTANEOUS ANGIO PACK-LF, Model Number DYNJ57645C; j) GENERAL ANGIO PACK, Model Number DYNJ57760C; k) ENSEMBLE ANGIOGRAPHIE-LF, Model Number DYNJ57792C; l) ANGIO PACK, Model Number DYNJ58111D; m) ANGIO PACK, Model Number DYNJ58111F; n) PORT PACK, Model Number DYNJ58162; o) ENSEMBLE ANGIO CEREBRALE-LF, Model Number DYNJ58178B; p) PERIPHERAL CATHETER #668236-V, Model Number DYNJ58510A; q) OR ANGIO PACK, Model Number DYNJ59184B; r) PORT A CATH PACK, Model Number DYNJ59307F; s) CATH PACK, Model Number DYNJ59632D; t) PACK PERCUTANEOUS ANGIO CHRG, Model Number DYNJ60112B; u) I.R. PACK, Model Number DYNJ60343B; v) I.R. PACK, Model Number DYNJ60343C; w) CATH LAB PACK, Model Number DYNJ60763; x) CRMC ANGIOGRAM-LF, Model Number DYNJ61082C; y) CRMC ANGIOGRAM-LF, Model Number DYNJ61082D; z) CRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099B; aa) CRMC MINOR IR PROCEDURE PK-LF, Model Number DYNJ61099C; bb) CRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118C; cc) CRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118D; dd) CRMC TUNNEL CATH TRAY-LF, Model Number DYNJ61118F; ee) MAIN OR CATH LAB, Model Number DYNJ61373A; ff) CARDIAC CATH PACK-LF, Model Number DYNJ61527A; gg) IR PACK, Model Number DYNJ61646A; hh) PERMA CATH PACK, Model Number DYNJ62007A; ii) IR PACK, Model Number DYNJ62037D; jj) AV FISTULA PACK, Model Number DYNJ62733A; kk) ANGIOGRAPHY DRAPE PACK, Model Number DYNJ63060B; ll) CATH PACK, Model Number DYNJ63181A; mm) CATH PACK, Model Number DYNJ63181B; nn) CATH PACK, Model Number DYNJ63181C; oo) CATH ANGIO PACK, Model Number DYNJ64050A; pp) ANGIOPLASTY PACK-LF, Model Number DYNJ64655C; qq) IR GENERAL PACK, Model Number DYNJ64976; rr) HEART TAVR PACK, Model Number DYNJ65174D; ss) ANGIOGRAPHY PACK, Model Number DYNJ65190D; tt) ANGIOGRAPHY PACK, Model Number DYNJ65190F; uu) PACK,CARDIAC CATH, Model Number DYNJ65481; vv) RADIOFREQUENCY ABLATION PACK, Model Number DYNJ65913; ww) CATH LAB PACK, Model Number DYNJ66166A; xx) CATH I W SPLIT DRAPE PACK, Model Number DYNJ66182; yy) PORT A CATH INSERT PK, Model Number DYNJ66257; zz) PORT A CATH INSERT PK, Model Number DYNJ66257A; aaa) PORT A CATH INSERT PK, Model Number DYNJ66257B; bbb) FISTULAGRAM PACK, Model Number DYNJ66259A; ccc) ANGIOGRAM SET UP PACK, Model Number DYNJ66260A; ddd) CATH PACK, Model Number DYNJ66473A; eee) ANGIOGRAPHY PACK, Model Number DYNJ66476A; fff) FEMORAL PACK, Model Number DYNJ66515A; ggg) IR PACK UNION, Model Number DYNJ66926A; hhh) STANDARD ANGIO TRAY MV, Model Number DYNJ67136A; iii) ANGIOGRAPHY PACK, Model Number DYNJ67144A; jjj) DRAINAGE PROCEDURE PACK, Model Number DYNJ67149A; kkk) CARDIAC CATH PACK, Model Number DYNJ67174A; lll) CARDIAC CATH PACK, Model Number DYNJ67174B; mmm) OR ANGIOGRAPHY PACK, Model Number DYNJ67245A; nnn) OR ANGIOGRAPHY PACK, Model Number DYNJ67245B; ooo) ANGIOGRAPHIC TRAY, Model Number DYNJ67320A; ppp) IR PACK, Model Number DYNJ67737; qqq) TUNNEL LINE PACK, Model Number DYNJ67990A; rrr) ANGIOGRAPHY DRAPE PACK, Model Number DYNJ68065B; sss) NEURO RADIOLOGY RICHMOND, Model Number DYNJ68365B; ttt) IR PACK, Model Number DYNJ68538; uuu) SPECIAL PROCEDURE CATH LAB PK, Model Number DYNJ68729; vvv) IR PACK, Model Number DYNJ68729B; www) CATH LAB ANGIO TRAY, Model Number DYNJ68763; xxx) CATH LAB ANGIO TRAY, Model Number DYNJ68763A; yyy) IR RADIOLOGY PACK, Model Number DYNJ69056; zzz) IR RADIOLOGY PACK, Model Number DYNJ69056A; aaaa) ANGIO PACK, Model Number DYNJ69200; bbbb) HGH TAVI PACK, Model Number DYNJ69298; cccc) ANGIO TRAY, Model Number DYNJ69421; dddd) ENDOV
Code Information all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ55252C, UDI/DI (EA)10195327267919, UDI/DI (CS)40195327267910; b) Model Number DYNJ55455A, UDI/DI (EA)10193489386233, UDI/DI (CS)40193489386234; c) Model Number DYNJ55680A, UDI/DI (EA)10889942639786, UDI/DI (CS)40889942639787; d) Model Number DYNJ56038A, UDI/DI (EA)10195327347840, UDI/DI (CS)40195327347841; e) Model Number DYNJ56547C, UDI/DI (EA)10193489879834, UDI/DI (CS)40193489879835; f) Model Number DYNJ57049G, UDI/DI (EA)10195327110390, UDI/DI (CS)40195327110391; g) Model Number DYNJ57049I, UDI/DI (EA)10195327207731, UDI/DI (CS)40195327207732; h) Model Number DYNJ57049J, UDI/DI (EA)10195327290658, UDI/DI (CS)40195327290659; i) Model Number DYNJ57645C, UDI/DI (EA)10195327287412, UDI/DI (CS)40195327287413; j) Model Number DYNJ57760C, UDI/DI (EA)10195327079390, UDI/DI (CS)40195327079391; k) Model Number DYNJ57792C, UDI/DI (EA)10195327209902, UDI/DI (CS)40195327209903; l) Model Number DYNJ58111D, UDI/DI (EA)10193489932928, UDI/DI (CS)40193489932929; m) Model Number DYNJ58111F, UDI/DI (EA)10195327223519, UDI/DI (CS)40195327223510; n) Model Number DYNJ58162, UDI/DI (EA)10889942829330, UDI/DI (CS)40889942829331; o) Model Number DYNJ58178B, UDI/DI (EA)10195327209919, UDI/DI (CS)40195327209910; p) Model Number DYNJ58510A, UDI/DI (EA)10193489817430, UDI/DI (CS)40193489817431; q) Model Number DYNJ59184B, UDI/DI (EA)10193489949100, UDI/DI (CS)40193489949101; r) Model Number DYNJ59307F, UDI/DI (EA)10195327058852, UDI/DI (CS)40195327058853; s) Model Number DYNJ59632D, UDI/DI (EA)10195327034078, UDI/DI (CS)40195327034079; t) Model Number DYNJ60112B, UDI/DI (EA)10195327118846, UDI/DI (CS)40195327118847; u) Model Number DYNJ60343B, UDI/DI (EA)10195327215491, UDI/DI (CS)40195327215492; v) Model Number DYNJ60343C, UDI/DI (EA)10195327285043, UDI/DI (CS)40195327285044; w) Model Number DYNJ60763, UDI/DI (EA)10193489527964, UDI/DI (CS)40193489527965; x) Model Number DYNJ61082C, UDI/DI (EA)10195327111410, UDI/DI (CS)40195327111411; y) Model Number DYNJ61082D, UDI/DI (EA)10195327261993, UDI/DI (CS)40195327261994; z) Model Number DYNJ61099B, UDI/DI (EA)10195327111854, UDI/DI (CS)40195327111855; aa) Model Number DYNJ61099C, UDI/DI (EA)10195327262006, UDI/DI (CS)40195327262007; bb) Model Number DYNJ61118C, UDI/DI (EA)10193489463972, UDI/DI (CS)40193489463973; cc) Model Number DYNJ61118D, UDI/DI (EA)10195327108212, UDI/DI (CS)40195327108213; dd) Model Number DYNJ61118F, UDI/DI (EA)10195327261986, UDI/DI (CS)40195327261987; ee) Model Number DYNJ61373A, UDI/DI (EA)10195327014698, UDI/DI (CS)40195327014699; ff) Model Number DYNJ61527A, UDI/DI (EA)10195327383800, UDI/DI (CS)40195327383801; gg) Model Number DYNJ61646A, UDI/DI (EA)10195327014315, UDI/DI (CS)40195327014316; hh) Model Number DYNJ62007A, UDI/DI (EA)10193489878905, UDI/DI (CS)40193489878906; ii) Model Number DYNJ62037D, UDI/DI (EA)10193489893694, UDI/DI (CS)40193489893695; jj) Model Number DYNJ62733A, UDI/DI (EA)10193489970678, UDI/DI (CS)40193489970679; kk) Model Number DYNJ63060B, UDI/DI (EA)10193489912821, UDI/DI (CS)40193489912822; ll) Model Number DYNJ63181A, UDI/DI (EA)10195327045487, UDI/DI (CS)40195327045488; mm) Model Number DYNJ63181B, UDI/DI (EA)10195327127213, UDI/DI (CS)40195327127214; nn) Model Number DYNJ63181C, UDI/DI (EA)10195327242008, UDI/DI (CS)40195327242009; oo) Model Number DYNJ64050A, UDI/DI (EA)10193489943825, UDI/DI (CS)40193489943826; pp) Model Number DYNJ64655C, UDI/DI (EA)10195327172893, UDI/DI (CS)40195327172894; qq) Model Number DYNJ64976, UDI/DI (EA)10193489237122, UDI/DI (CS)40193489237123; rr) Model Number DYNJ65174D, UDI/DI (EA)10193489962154, UDI/DI (CS)40193489962155; ss) Model Number DYNJ65190D, UDI/DI (EA)10195327066642, UDI/DI (CS)40195327066643; tt) Model Number DYNJ65190F, UDI/DI (EA)10195327092658, UDI/DI (CS)40195327092659; uu) Model Number DYNJ65481, UDI/DI (EA)10193489280463, UDI/DI (CS)40193489280464; vv) Model Number DYNJ65913, UDI/DI (EA)10193489303179, UDI/DI (CS)40193489303170; ww) Model Number DYNJ66166A, UDI/DI (EA)10193489395990, UDI/DI (CS)40193489395991; xx) Model Number DYNJ66182, UDI/DI (EA)10193489320985, UDI/DI (CS)40193489320986; yy) Model Number DYNJ66257, UDI/DI (EA)10193489325492, UDI/DI (CS)40193489325493; zz) Model Number DYNJ66257A, UDI/DI (EA)10193489947502, UDI/DI (CS)40193489947503; aaa) Model Number DYNJ66257B, UDI/DI (EA)10195327185831, UDI/DI (CS)40195327185832; bbb) Model Number DYNJ66259A, UDI/DI (EA)10195327185732, UDI/DI (CS)40195327185733; ccc) Model Number DYNJ66260A, UDI/DI (EA)10195327185749, UDI/DI (CS)40195327185740; ddd) Model Number DYNJ66473A, UDI/DI (EA)10193489917772, UDI/DI (CS)40193489917773; eee) Model Number DYNJ66476A, UDI/DI (EA)10195327051891, UDI/DI (CS)40195327051892; fff) Model Number DYNJ66515A, UDI/DI (EA)10193489406160, UDI/DI (CS)40193489406161; ggg) Model Number DYNJ66926A, UDI/DI (EA)10193489887358, UDI/DI (CS)40193489887359; hhh) Model Number DYNJ67136A, UDI/DI (EA)10193489935677, UDI/DI (CS)40193489935678; iii) Model Number DYNJ67144A, UDI/DI (EA)10195327179021, UDI/DI (CS)40195327179022; jjj) Model Number DYNJ67149A, UDI/DI (EA)10195327179038, UDI/DI (CS)40195327179039; kkk) Model Number DYNJ67174A, UDI/DI (EA)10195327046804, UDI/DI (CS)40195327046805; lll) Model Number DYNJ67174B, UDI/DI (EA)10195327131081, UDI/DI (CS)40195327131082; mmm) Model Number DYNJ67245A, UDI/DI (EA)10195327024253, UDI/DI (CS)40195327024254; nnn) Model Number DYNJ67245B, UDI/DI (EA)10195327292225, UDI/DI (CS)40195327292226; ooo) Model Number DYNJ67320A, UDI/DI (EA)10193489937572, UDI/DI (CS)40193489937573; ppp) Model Number DYNJ67737, UDI/DI (EA)10193489427752, UDI/DI (CS)40193489427753; qqq) Model Number DYNJ67990A, UDI/DI (EA)10195327265335, UDI/DI (CS)40195327265336; rrr) Model Number DYNJ68065B, UDI/DI (EA)10195327013332, UDI/DI (CS)40195327013333; sss) Model Number DYNJ68365B, UDI/DI (EA)10195327161934, UDI/DI (CS)40195327161935; ttt) Model Number DYNJ68538, UDI/DI (EA)10193489833119, UDI/DI (CS)40193489833110; uuu) Model Number DYNJ68729, UDI/DI (EA)10193489836547, UDI/DI (CS)40193489836548; vvv) Model Number DYNJ68729B, UDI/DI (EA)10195327020910, UDI/DI (CS)40195327020911; www) Model Number DYNJ68763, UDI/DI (EA)10193489837599, UDI/DI (CS)40193489837590; xxx) Model Number DYNJ68763A, UDI/DI (EA)10195327264789, UDI/DI (CS)40195327264780; yyy) Model Number DYNJ69056, UDI/DI (EA)10193489886870, UDI/DI (CS)40193489886871; zzz) Model Number DYNJ69056A, UDI/DI (EA)10195327061296, UDI/DI (CS)40195327061297; aaaa) Model Number DYNJ69200, UDI/DI (EA)10193489906813, UDI/DI (CS)40193489906814; bbbb) Model Number DYNJ69298, UDI/DI (EA)10193489925418, UDI/DI (CS)40193489925419; cccc) Model Number DYNJ69421, UDI/DI (EA)10193489937596, UDI/DI (CS)40193489937597; dddd) Model Number DYNJ69691, UDI/DI (EA)10193489970111, UDI/DI (CS)40193489970112; eeee) Model Number DYNJ69742B, UDI/DI (EA)10195327136888, UDI/DI (CS)40195327136889; ffff) Model Number DYNJ69763A, UDI/DI (EA)10195327330019, UDI/DI (CS)40195327330010; gggg) Model Number DYNJ69864, UDI/DI (EA)10193489990485, UDI/DI (CS)40193489990486; hhhh) Model Number DYNJ69944, UDI/DI (EA)10193489998450, UDI/DI (CS)40193489998451; iiii) Model Number DYNJ69944A, UDI/DI (EA)10195327285364, UDI/DI (CS)40195327285365; jjjj) Model Number DYNJ69951, UDI/DI (EA)10195327000301, UDI/DI (CS)40195327000302; kkkk) Model Number DYNJ80269, UDI/DI (EA)10195327017804, UDI/DI (CS)40195327017805; llll) Model Number DYNJ80297, UDI/DI (EA)10195327021771, UDI/DI (CS)40195327021772; mmmm) Model Number DYNJ80297A, UDI/DI (EA)10195327372170, UDI/DI (CS)40195327372171; nnnn) Model Number DYNJ81213, UDI/DI (EA)10195327094270, UDI/DI (CS)40195327094271; oooo) Model Number DYNJ81213A, UDI/DI (EA)10195327319250, UDI/DI (CS)40195327319251; pppp) Model Number DYNJ81316, UDI/DI (EA)10195327103798, UDI/DI (CS)40195327103799; qqqq) Model Number DYNJ81429A, UDI/DI (EA)10195327321642, UDI/DI (CS)40195327321643; rrrr) Model Number DYNJ81435B, UDI/DI (EA)10195327324834, UDI/DI (CS)40195327324835; ssss) Model Number DYNJ82030, UDI/DI (EA)10195327162375, UDI/DI (CS)40195327162376; tttt) Model Number DYNJ82041, UDI/DI (EA)10195327162214, UDI/DI (CS)40195327162215; uuuu) Model Number DYNJ82079, UDI/DI (EA)10195327167363, UDI/DI (CS)40195327167364; vvvv) Model Number DYNJ82280, UDI/DI (EA)10195327183929, UDI/DI (CS)40195327183920; wwww) Model Number DYNJ82296, UDI/DI (EA)10195327184209, UDI/DI (CS)40195327184200; xxxx) Model Number DYNJ82999, UDI/DI (EA)10195327223106, UDI/DI (CS)40195327223107; yyyy) Model Number DYNJ82999A, UDI/DI (EA)10195327310271, UDI/DI (CS)40195327310272; zzzz) Model Number DYNJ83089, UDI/DI (EA)10195327230838, UDI/DI (CS)40195327230839;
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 3,740,814 units in 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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