Class 2 Device Recall Medline Probe Cover Kits

• Date Initiated by Firm: May 18, 2023
• Date Posted: July 20, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2160-2023
• 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 DRAPE PACK, Model Number 00-400305R; b) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C; c) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D; d) ANGIOGRAM, Model Number DYNJ0149444N; e) DIALYSIS CATH INSERTION PK-LF, Model Number DYNJ0198765G; f) PICC LINE PACK-LF, Model Number DYNJ0275614F; g) ANGIOGRAPHY PACK-LF, Model Number DYNJ0290716M; h) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233V; i) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233W; j) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233X; k) ANGIO PACK-LF, Model Number DYNJ0407399P; l) SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535AA; m) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121K; n) CARDIAC EP PACK-LF, Model Number DYNJ0429185L; o) SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0458661C; p) LT HEART/ANGIOGRAPHY PACK-LF, Model Number DYNJ0537652AG; q) CATH LAB ANGIO PACK-LF, Model Number DYNJ0545064AA; r) SPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508R; s) CARDIAC CATH PACK-LF, Model Number DYNJ0842644F; t) PEDIATRIC CATH PACK-LF, Model Number DYNJ0843244K; u) ANGIOGRAPHY PACK-LF, Model Number DYNJ0854485V; v) CARDIAC CATH PACK-LF, Model Number DYNJ0855138P; w) CARDIAC CATH PACK-LF, Model Number DYNJ0855138Q; x) IR PICC PACK-LF, Model Number DYNJ0950839C; y) SPECIAL PROCEDURES, Model Number DYNJ23288C; z) ANGIO TRAY, Model Number DYNJ23438M; aa) ADULT CARDIAC CATH PACK, Model Number DYNJ23455K; bb) ADULT CARDIAC CATH PACK, Model Number DYNJ23455L; cc) ADULT CARDIAC CATH PACK, Model Number DYNJ23455M; dd) ADULT CARDIAC CATH PACK, Model Number DYNJ23455N; ee) STENT PACK-LF, Model Number DYNJ27613K; ff) CATH I W/ ANGIO DRAPE, Model Number DYNJ33709F; gg) JUGULAR PACK, Model Number DYNJ35164C; hh) ANGIO DRAPE PACK RADIOLOGY-LF, Model Number DYNJ35993F; ii) ANGIO DRAPE II-LF, Model Number DYNJ35994C; jj) ANGIO/PICC PACK, Model Number DYNJ36049A; kk) ISSAQUA CATH/IR PACK, Model Number DYNJ36738G; ll) IR PACK, Model Number DYNJ36752B; mm) ARTERIOGRAM TRAY-LF, Model Number DYNJ36807C; nn) SPECIAL PROCEDURE PACK, Model Number DYNJ38314G; oo) MINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326G; pp) CARDIAC CATH PACK, Model Number DYNJ38866F; qq) INTERVENTIONAL RAD L J-LF, Model Number DYNJ40215B; rr) ABLATION PACK, Model Number DYNJ40629C; ss) CATH LAB PACK, Model Number DYNJ40926A; tt) RADIOLOGY PACK, Model Number DYNJ41190; uu) TV IR PACK-LF, Model Number DYNJ41562F; vv) CUSTOM ANGIO TRAY, Model Number DYNJ41649G; ww) CARDIAC CATH DRAPE PACK, Model Number DYNJ41700A; xx) IR PACK, Model Number DYNJ41989G; yy) INTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ42231C; zz) ANGIO PACK, Model Number DYNJ42903C; aaa) ANGIO PACK, Model Number DYNJ42903D; bbb) CARDIAC CATH PACK-LF, Model Number DYNJ42996C; ccc) DIALYSIS TRAY, Model Number DYNJ43060B; ddd) ANGIOPLASTY PACK-LF, Model Number DYNJ43203G; eee) ARTERIOGRAM PACK, Model Number DYNJ43261J; fff) CATH LAB RIGHT HEART PACK, Model Number DYNJ43315L; ggg) ANGIO CATH COMBINED PACK, Model Number DYNJ43609P; hhh) ANGIO CATH COMBINED PACK, Model Number DYNJ43609R; iii) ANGIO CATH COMBINED PACK, Model Number DYNJ43609S; jjj) ANGIO PACK, Model Number DYNJ43661C; kkk) ABLATION EP PACK, Model Number DYNJ43851B; lll) PK, RADIOLOGY, Model Number DYNJ43894B; mmm) PK, RADIOLOGY, Model Number DYNJ44087A; nnn) ANGIOGRAPHY PACK, Model Number DYNJ44293F; ooo) ANGIO DRAPE PACK, Model Number DYNJ44320G; ppp) ANGIO DRAPE PACK, Model Number DYNJ44320I; qqq) ANGIO DRAPE PACK, Model Number DYNJ44320J; rrr) FEMORAL ANGIO PACK, Model Number DYNJ44334M; sss) FEMORAL ANGIO PACK, Model Number DYNJ44334N; ttt) RADIOLOGY PACK, Model Number DYNJ44524F; uuu) ANGIO PACK, Model Number DYNJ44642B; vvv) ANGIOPLASTY PACK, Model Number DYNJ44700J; www) ANGIO PACK, Model Number DYNJ44993J; xxx) ANGIOGRAPHY PACK, Model Number DYNJ45059B; yyy) PERCUTANEOUS PACK, Model Number D
• Code Information: all lots within expiry, distributed from Medline between December 2017- May 2023: a) Model Number 00-400305R, UDI/DI (EA) 10193489944280, UDI/DI (CS) 40193489944281; b) Model Number DYNJ0037936C, UDI/DI (EA) 10195327031282, UDI/DI (CS) 40195327031283; c) Model Number DYNJ0037936D, UDI/DI (EA) 10195327129538, UDI/DI (CS) 40195327129539; d) Model Number DYNJ0149444N, UDI/DI (EA) 10193489966718, UDI/DI (CS) 40193489966719; e) Model Number DYNJ0198765G, UDI/DI (EA) 10889942053988, UDI/DI (CS) 40889942053989; f) Model Number DYNJ0275614F, UDI/DI (EA) 10889942174348, UDI/DI (CS) 40889942174349; g) Model Number DYNJ0290716M, UDI/DI (EA) 10195327088866, UDI/DI (CS) 40195327088867; h) Model Number DYNJ0313233V, UDI/DI (EA) 10889942247356, UDI/DI (CS) 40889942247357; i) Model Number DYNJ0313233W, UDI/DI (EA) 10195327110970, UDI/DI (CS) 40195327110971; j) Model Number DYNJ0313233X, UDI/DI (EA) 10195327250980, UDI/DI (CS) 40195327250981; k) Model Number DYNJ0407399P, UDI/DI (EA) 10195327336868, UDI/DI (CS) 40195327336869; l) Model Number DYNJ0416535AA, UDI/DI (EA) 10195327354596, UDI/DI (CS) 40195327354597; m) Model Number DYNJ0429121K, UDI/DI (EA) 10195327069506, UDI/DI (CS) 40195327069507; n) Model Number DYNJ0429185L, UDI/DI (EA) 10195327048976, UDI/DI (CS) 40195327048977; o) Model Number DYNJ0458661C, UDI/DI (EA) 10889942550944, UDI/DI (CS) 40889942550945; p) Model Number DYNJ0537652AG, UDI/DI (EA) 10195327017675, UDI/DI (CS) 40195327017676; q) Model Number DYNJ0545064AA, UDI/DI (EA) 10195327327385, UDI/DI (CS) 40195327327386; r) Model Number DYNJ0604508R, UDI/DI (EA) 10193489828443, UDI/DI (CS) 40193489828444; s) Model Number DYNJ0842644F, UDI/DI (EA) 10195327288600, UDI/DI (CS) 40195327288601; t) Model Number DYNJ0843244K, UDI/DI (EA) 10195327288594, UDI/DI (CS) 40195327288595; u) Model Number DYNJ0854485V, UDI/DI (EA) 10195327096885, UDI/DI (CS) 40195327096886; v) Model Number DYNJ0855138P, UDI/DI (EA) 10193489885132, UDI/DI (CS) 40193489885133; w) Model Number DYNJ0855138Q, UDI/DI (EA) 10195327094843, UDI/DI (CS) 40195327094844; x) Model Number DYNJ0950839C, UDI/DI (EA) 10889942101290, UDI/DI (CS) 40889942101291; y) Model Number DYNJ23288C, UDI/DI (EA) 10193489954142, UDI/DI (CS) 40193489954143; z) Model Number DYNJ23438M, UDI/DI (EA) 10193489970609, UDI/DI (CS) 40193489970600; aa) Model Number DYNJ23455K, UDI/DI (EA) 10193489446296, UDI/DI (CS) 40193489446297; bb) Model Number DYNJ23455L, UDI/DI (EA) 10193489977387, UDI/DI (CS) 40193489977388; cc) Model Number DYNJ23455M, UDI/DI (EA) 10195327129835, UDI/DI (CS) 40195327129836; dd) Model Number DYNJ23455N, UDI/DI (EA) 10195327237752, UDI/DI (CS) 40195327237753; ee) Model Number DYNJ27613K, UDI/DI (EA) 10195327131180, UDI/DI (CS) 40195327131181; ff) Model Number DYNJ33709F, UDI/DI (EA) 10889942713929, UDI/DI (CS) 40889942713920; gg) Model Number DYNJ35164C, UDI/DI (EA) 10889942494668, UDI/DI (CS) 40889942494669; hh) Model Number DYNJ35993F, UDI/DI (EA) 10195327398286, UDI/DI (CS) 40195327398287; ii) Model Number DYNJ35994C, UDI/DI (EA) 10195327397951, UDI/DI (CS) 40195327397952; jj) Model Number DYNJ36049A, UDI/DI (EA) 10195327147204, UDI/DI (CS) 40195327147205; kk) Model Number DYNJ36738G, UDI/DI (EA) 10195327054168, UDI/DI (CS) 40195327054169; ll) Model Number DYNJ36752B, UDI/DI (EA) 10195327226022, UDI/DI (CS) 40195327226023; mm) Model Number DYNJ36807C, UDI/DI (EA) 10195327082222, UDI/DI (CS) 40195327082223; nn) Model Number DYNJ38314G, UDI/DI (EA) 10193489603347, UDI/DI (CS) 40193489603348; oo) Model Number DYNJ38326G, UDI/DI (EA) 10195327230135, UDI/DI (CS) 40195327230136; pp) Model Number DYNJ38866F, UDI/DI (EA) 10193489914863, UDI/DI (CS) 40193489914864; qq) Model Number DYNJ40215B, UDI/DI (EA) 10888277912267, UDI/DI (CS) 40888277912268; rr) Model Number DYNJ40629C, UDI/DI (EA) 10193489997316, UDI/DI (CS) 40193489997317; ss) Model Number DYNJ40926A, UDI/DI (EA) 10195327137212, UDI/DI (CS) 40195327137213; tt) Model Number DYNJ41190, UDI/DI (EA) 10884389899083, UDI/DI (CS) 40884389899084; uu) Model Number DYNJ41562F, UDI/DI (EA) 10193489641080, UDI/DI (CS) 40193489641081; vv) Model Number DYNJ41649G, UDI/DI (EA) 10195327277291, UDI/DI (CS) 40195327277292; ww) Model Number DYNJ41700A, UDI/DI (EA) 10889942756957, UDI/DI (CS) 40889942756958; xx) Model Number DYNJ41989G, UDI/DI (EA) 10193489310801, UDI/DI (CS) 40193489310802; yy) Model Number DYNJ42231C, UDI/DI (EA) 10195327026561, UDI/DI (CS) 40195327026562; zz) Model Number DYNJ42903C, UDI/DI (EA) 10195327079666, UDI/DI (CS) 40195327079667; aaa) Model Number DYNJ42903D, UDI/DI (EA) 10195327171117, UDI/DI (CS) 40195327171118; bbb) Model Number DYNJ42996C, UDI/DI (EA) 10193489988437, UDI/DI (CS) 40193489988438; ccc) Model Number DYNJ43060B, UDI/DI (EA) 10889942765850, UDI/DI (CS) 40889942765851; ddd) Model Number DYNJ43203G, UDI/DI (EA) 10193489952919, UDI/DI (CS) 40193489952910; eee) Model Number DYNJ43261J, UDI/DI (EA) 10195327288792, UDI/DI (CS) 40195327288793; fff) Model Number DYNJ43315L, UDI/DI (EA) 10193489463675, UDI/DI (CS) 40193489463676; ggg) Model Number DYNJ43609P, UDI/DI (EA) 10193489914535, UDI/DI (CS) 40193489914536; hhh) Model Number DYNJ43609R, UDI/DI (EA) 10195327228781, UDI/DI (CS) 40195327228782; iii) Model Number DYNJ43609S, UDI/DI (EA) 10195327322984, UDI/DI (CS) 40195327322985; jjj) Model Number DYNJ43661C, UDI/DI (EA) 10195327104351, UDI/DI (CS) 40195327104352; kkk) Model Number DYNJ43851B, UDI/DI (EA) 10195327200329, UDI/DI (CS) 40195327200320; lll) Model Number DYNJ43894B, UDI/DI (EA) 10193489810486, UDI/DI (CS) 40193489810487; mmm) Model Number DYNJ44087A, UDI/DI (EA) 10889942561803, UDI/DI (CS) 40889942561804; nnn) Model Number DYNJ44293F, UDI/DI (EA) 10195327265182, UDI/DI (CS) 40195327265183; ooo) Model Number DYNJ44320G, UDI/DI (EA) 10193489966305, UDI/DI (CS) 40193489966306; ppp) Model Number DYNJ44320I, UDI/DI (EA) 10195327070359, UDI/DI (CS) 40195327070350; qqq) Model Number DYNJ44320J, UDI/DI (EA) 10195327132354, UDI/DI (CS) 40195327132355; rrr) Model Number DYNJ44334M, UDI/DI (EA) 10195327133115, UDI/DI (CS) 40195327133116; sss) Model Number DYNJ44334N, UDI/DI (EA) 10195327299491, UDI/DI (CS) 40195327299492; ttt) Model Number DYNJ44524F, UDI/DI (EA) 10193489467482, UDI/DI (CS) 40193489467483; uuu) Model Number DYNJ44642B, UDI/DI (EA) 10195327011420, UDI/DI (CS) 40195327011421; vvv) Model Number DYNJ44700J, UDI/DI (EA) 10195327277413, UDI/DI (CS) 40195327277414; www) Model Number DYNJ44993J, UDI/DI (EA) 10195327380922, UDI/DI (CS) 40195327380923; xxx) Model Number DYNJ45059B, UDI/DI (EA) 10889942135639, UDI/DI (CS) 40889942135630; yyy) Model Number DYNJ46035D, UDI/DI (EA) 10193489493641, UDI/DI (CS) 40193489493642; zzz) Model Number DYNJ46545B, UDI/DI (EA) 10195327008246, UDI/DI (CS) 40195327008247; aaaa) Model Number DYNJ46545C, UDI/DI (EA) 10195327250423, UDI/DI (CS) 40195327250424; bbbb) Model Number DYNJ47645B, UDI/DI (EA) 10193489952834, UDI/DI (CS) 40193489952835; cccc) Model Number DYNJ47646D, UDI/DI (EA) 10193489950472, UDI/DI (CS) 40193489950473; dddd) Model Number DYNJ47646F, UDI/DI (EA) 10195327155513, UDI/DI (CS) 40195327155514; eeee) Model Number DYNJ47646G, UDI/DI (EA) 10195327175023, UDI/DI (CS) 40195327175024; ffff) Model Number DYNJ47646I, UDI/DI (EA) 10195327357122, UDI/DI (CS) 40195327357123; gggg) Model Number DYNJ47665D, UDI/DI (EA) 10193489952827, UDI/DI (CS) 40193489952828; hhhh) Model Number DYNJ47665F, UDI/DI (EA) 10195327355210, UDI/DI (CS) 40195327355211; iiii) Model Number DYNJ49621C, UDI/DI (EA) 10195327008581, UDI/DI (CS) 40195327008582; jjjj) Model Number DYNJ50694A, UDI/DI (EA) 10889942693511, UDI/DI (CS) 40889942693512; kkkk) Model Number DYNJ50712D, UDI/DI (EA) 10195327267926, UDI/DI (CS) 40195327267927; llll) Model Number DYNJ51109B, UDI/DI (EA) 10889942456314, UDI/DI (CS) 40889942456315; mmmm) Model Number DYNJ51240A, UDI/DI (EA) 10889942493524, UDI/DI (CS) 40889942493525; nnnn) Model Number DYNJ51338C, UDI/DI (EA) 10193489241716, UDI/DI (CS) 40193489241717; oooo) Model Number DYNJ52000B, UDI/DI (EA) 10193489384987, UDI/DI (CS) 40193489384988; pppp) Model Number DYNJ52121A, UDI/DI (EA) 10195327260095, UDI/DI (CS) 40195327260096; qqqq) Model Number DYNJ52425J, UDI/DI (EA) 10193489940145, UDI/DI (CS) 40193489940146; rrrr) Model Number DYNJ52425K, UDI/DI (EA) 10195327042356, UDI/DI (CS) 40195327042357; ssss) Model Number DYNJ52425L, UDI/DI (EA) 10195327074487, UDI/DI (CS) 40195327074488; tttt) Model Number DYNJ52425M, UDI/DI (EA) 10195327177188, UDI/DI (CS) 40195327177189; uuuu) Model Number DYNJ52425N, UDI/DI (EA) 10195327339326, UDI/DI (CS) 40195327339327; vvvv) Model Number DYNJ52774, UDI/DI (EA) 10889942322473, UDI/DI (CS) 40889942322474; wwww) Model Number DYNJ52806C, UDI/DI (EA) 10193489292909, UDI/DI (CS) 40193489292900; xxxx) Model Number DYNJ53095, UDI/DI (EA) 10889942371778, UDI/DI (CS) 40889942371779; yyyy) Model Number DYNJ53481D, UDI/DI (EA) 10193489812572, UDI/DI (CS) 40193489812573; zzzz) Model Number DYNJ54755I, UDI/DI (EA) 10195327021269, UDI/DI (CS) 40195327021260
• 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: 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: 173449 units
• 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.