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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-2163-2023
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. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b. PERCUTANEOUS VASCULAR CDS, Model Number CDS840487I; c. BAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I; d. ENDOVASCULAR CDS, Model Number CDS983394I; e. ENDOVASCULAR CDS, Model Number CDS983394J; f. ENDOVASCULAR CDS, Model Number CDS983394K; g. OPEN HEART CDS, Model Number CDS983513F; h. OPEN HEART ANESTHESIA PACK, Model Number CDS983849D; i. OPEN HEART ANESTHESIA PACK, Model Number CDS983849F; j. VNUS, Model Number CDS984292I; k. OPEN HEART CDS, Model Number CDS984355G; l. BEDSIDE PICC CDS, Model Number CDS984642; m. VASCULAR, Model Number CDS984764G; n. OPEN HEART A, Model Number CDS985105O; o. VASCULAR, Model Number CDS985355D; p. VASCULAR, Model Number CDS985355F; q. ECMO KIT, Model Number CVI4955; r. KIT CARDIAC CSICU ADULT ECMO, Model Number DYKMBNDL21; s. VASCULAR ACCESS PROCEDURE KIT, Model Number DYNDA2526; t. ARTERIAL/VENOUS ACCESS TRAY, Model Number DYNDC3038; u. DIAGNOSTIC RADIO HOLLAN PK-LF, Model Number DYNJ0037939B; v. OPEN HEART CABG PACK-LF, Model Number DYNJ0149567C; w. VASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AJ; x. OPEN HEART PACK-LF, Model Number DYNJ0371669N; y. CABG PACK, Model Number DYNJ0408782AA; z. CARDIAC EP PACK-LF, Model Number DYNJ0429185K; aa. CARDIAC EP PACK-LF, Model Number DYNJ0429185M; bb. OPEN HEART A & B PACK, Model Number DYNJ0450131AI; cc. VASCULAR PACK-LF, Model Number DYNJ0493141J; dd. RIGHT HEART PACK-LF, Model Number DYNJ0565558U; ee. ENDO VASCULAR PACK-LF, Model Number DYNJ0676055N; ff. LOWER ENDO VASCULAR PACK, Model Number DYNJ0678934G; gg. ENDOVASCULAR PACK, Model Number DYNJ0678934I; hh. RR-NEURO DBS HEAD PACK-LF, Model Number DYNJ0785736J; ii. ELECTROPHYSIOLOGY PACK-LF, Model Number DYNJ0842825D; jj. VASCULAR PACK-LF, Model Number DYNJ0871182AC; kk. ELECTROPHYSIOLOGY TRAY-LF, Model Number DYNJ09878D; ll. EP PACK, Model Number DYNJ16618J; mm. EP PACK, Model Number DYNJ16618K; nn. ST MARY'S STL OPEN HRT SUPPLY, Model Number DYNJ20031C; oo. VEIN PACK, Model Number DYNJ21949J; pp. VASCULAR PACK, Model Number DYNJ22350L; qq. EP PACK, Model Number DYNJ23456K; rr. ANGIO-VASCULAR, Model Number DYNJ24272C; ss. EP ANGIO PACK, Model Number DYNJ25749S; tt. C.V. MINOR PACK, Model Number DYNJ28849B; uu. EP TRAY, Model Number DYNJ31928D; vv. PACER PACK, Model Number DYNJ34844C; ww. ADULT CARDIO TRAY, Model Number DYNJ35495G; xx. PEDIATRIC CARDIO CATH PACK, Model Number DYNJ35578G; yy. CARDIO B PACK, Model Number DYNJ36052O; zz. VASCULAR ENDO LASER PK, Model Number DYNJ37445I; aaa. VEIN PROCEDURE PACK, Model Number DYNJ38264D; bbb. HMT VEIN PACK, Model Number DYNJ38756B; ccc. LASER AND VEIN PACK, Model Number DYNJ38995C; ddd. VEIN CLOSURE PACK, Model Number DYNJ39408F; eee. CAROTID PACK, Model Number DYNJ39488G; fff. VEIN PACK, Model Number DYNJ39889; ggg. CVL CUSTOM PACK, Model Number DYNJ40067G; hhh. AV GRAFT-LF, Model Number DYNJ40077F; iii. VASCULAR-LF, Model Number DYNJ40108I; jjj. INTERVENTIONAL RAD L J-LF, Model Number DYNJ40215C; kkk. RIGHT HEART TRAY, Model Number DYNJ40379D; lll. LINE PACK, Model Number DYNJ41100C; mmm. CARDIAC CATH PACK, Model Number DYNJ41195D; nnn. VEIN PK, Model Number DYNJ42976; ooo. VEIN CLOSURE PACK, Model Number DYNJ43085A; ppp. PROCEDURE PACK, Model Number DYNJ43922; qqq. PK, RADIOLOGY-PORTSMOUTH, Model Number DYNJ44087B; rrr. PACEMAKER PACK, Model Number DYNJ44345F; sss. PACEMAKER PACK, Model Number DYNJ44345G; ttt. VENOUS ACCESS PACK, Model Number DYNJ44421D; uuu. VEIN CLOSURE TRAY, Model Number DYNJ44737B; vvv. ENDO LASER ABLATION PK-LF, Model Number DYNJ44808G; www. PK, OPEN HEART, Model Number DYNJ45074C; xxx. VASCULAR PACK, Model Number DYNJ46246A; yyy. CVP PACK, Model Number DYNJ46359D; zzz. INTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ47138B; aaaa. EP DRAPE PACK-LF, Model Number DYNJ47645C; bbbb. RF OPEN HEAR
Code Information all lots within expiry, distributed from Medline between December 2017 May 2023: a) Model Number 00-401185Q, UDI/DI (EA) 10193489489088, UDI/DI (CS)40193489489089; b) Model Number CDS840487I, UDI/DI (EA) 10193489445343, UDI/DI (CS)40193489445344; c) Model Number CDS983147I, UDI/DI (EA) 10195327075514, UDI/DI (CS)40195327075515; d) Model Number CDS983394I, UDI/DI (EA) 10193489819953, UDI/DI (CS)40193489819954; e) Model Number CDS983394J, UDI/DI (EA) 10195327069872, UDI/DI (CS)40195327069873; f) Model Number CDS983394K, UDI/DI (EA) 10195327292584, UDI/DI (CS)40195327292585; g) Model Number CDS983513F, UDI/DI (EA) 10193489843729, UDI/DI (CS)40193489843720; h) Model Number CDS983849D, UDI/DI (EA) 10193489278231, UDI/DI (CS)40193489278232; i) Model Number CDS983849F, UDI/DI (EA) 10195327228316, UDI/DI (CS)40195327228317; j) Model Number CDS984292I, UDI/DI (EA) 10193489862485, UDI/DI (CS)40193489862486; k) Model Number CDS984355G, UDI/DI (EA) 10193489484632, UDI/DI (CS)40193489484633; l) Model Number CDS984642, UDI/DI (EA) 10884389882924, UDI/DI (CS)40884389882925; m) Model Number CDS984764G, UDI/DI (EA) 10193489450293, UDI/DI (CS)40193489450294; n) Model Number CDS985105O, UDI/DI (EA) 10195327036249, UDI/DI (CS)40195327036240; o) Model Number CDS985355D, UDI/DI (EA) 10193489442779, UDI/DI (CS)40193489442770; p) Model Number CDS985355F, UDI/DI (EA) 10195327242626, UDI/DI (CS)40195327242627; q) Model Number CVI4955, UDI/DI (EA) 10195327325848, UDI/DI (CS)40195327325849; r) Model Number DYKMBNDL21, UDI/DI (EA) 10193489478693, UDI/DI (CS)40193489478694; s) Model Number DYNDA2526, UDI/DI (EA) 10193489191790, UDI/DI (CS)40193489191791; t) Model Number DYNDC3038, UDI/DI (EA) 10193489493603, UDI/DI (CS)40193489493604; u) Model Number DYNJ0037939B, UDI/DI (EA) 10195327031275, UDI/DI (CS)40195327031276; v) Model Number DYNJ0149567C, UDI/DI (EA) 10195327235529, UDI/DI (CS)40195327235520; w) Model Number DYNJ0201109AJ, UDI/DI (EA) 10195327325459, UDI/DI (CS)40195327325450; x) Model Number DYNJ0371669N, UDI/DI (EA) 10193489230390, UDI/DI (CS)40193489230391; y) Model Number DYNJ0408782AA, UDI/DI (EA) 10195327115814, UDI/DI (CS)40195327115815; z) Model Number DYNJ0429185K, UDI/DI (EA) 10193489728132, UDI/DI (CS)40193489728133; aa) Model Number DYNJ0429185M, UDI/DI (EA) 10195327371357, UDI/DI (CS)40195327371358; bb) Model Number DYNJ0450131AI, UDI/DI (EA) 10193489466126, UDI/DI (CS)40193489466127; cc) Model Number DYNJ0493141J, UDI/DI (EA) 10193489926224, UDI/DI (CS)40193489926225; dd) Model Number DYNJ0565558U, UDI/DI (EA) 10193489827033, UDI/DI (CS)40193489827034; ee) Model Number DYNJ0676055N, UDI/DI (EA) 10193489954364, UDI/DI (CS)40193489954365; ff) Model Number DYNJ0678934G, UDI/DI (EA) 10193489925265, UDI/DI (CS)40193489925266; gg) Model Number DYNJ0678934I, UDI/DI (EA) 10193489997866, UDI/DI (CS)40193489997867; hh) Model Number DYNJ0785736J, UDI/DI (EA) 10193489202663, UDI/DI (CS)40193489202664; ii) Model Number DYNJ0842825D, UDI/DI (EA) 10195327288617, UDI/DI (CS)40195327288618; jj) Model Number DYNJ0871182AC, UDI/DI (EA) 10195327330859, UDI/DI (CS)40195327330850; kk) Model Number DYNJ09878D, UDI/DI (EA) 10195327387662, UDI/DI (CS)40195327387663; ll) Model Number DYNJ16618J, UDI/DI (EA) 10195327249854, UDI/DI (CS)40195327249855; mm) Model Number DYNJ16618K, UDI/DI (EA) 10195327325572, UDI/DI (CS)40195327325573; nn) Model Number DYNJ20031C, UDI/DI (EA) 10884389650073, UDI/DI (CS)40884389650074; oo) Model Number DYNJ21949J, UDI/DI (EA) 10889942128419, UDI/DI (CS)40889942128410; pp) Model Number DYNJ22350L, UDI/DI (EA) 10193489445251, UDI/DI (CS)40193489445252; qq) Model Number DYNJ23456K, UDI/DI (EA) 10193489967760, UDI/DI (CS)40193489967761; rr) Model Number DYNJ24272C, UDI/DI (EA) 10193489620221, UDI/DI (CS)40193489620222; ss) Model Number DYNJ25749S, UDI/DI (EA) 10195327059705, UDI/DI (CS)40195327059706; tt) Model Number DYNJ28849B, UDI/DI (EA) 10195327319557, UDI/DI (CS)40195327319558; uu) Model Number DYNJ31928D, UDI/DI (EA) 10195327335281, UDI/DI (CS)40195327335282; vv) Model Number DYNJ34844C, UDI/DI (EA) 10193489778076, UDI/DI (CS)40193489778077; ww) Model Number DYNJ35495G, UDI/DI (EA) 10193489803990, UDI/DI (CS)40193489803991; xx) Model Number DYNJ35578G, UDI/DI (EA) 10193489808605, UDI/DI (CS)40193489808606; yy) Model Number DYNJ36052O, UDI/DI (EA) 10195327249533, UDI/DI (CS)40195327249534; zz) Model Number DYNJ37445I, UDI/DI (EA) 10193489417395, UDI/DI (CS)40193489417396; aaa) Model Number DYNJ38264D, UDI/DI (EA) 10193489438499, UDI/DI (CS)40193489438490; bbb) Model Number DYNJ38756B, UDI/DI (EA) 10889942455799, UDI/DI (CS)40889942455790; ccc) Model Number DYNJ38995C, UDI/DI (EA) 10193489713145, UDI/DI (CS)40193489713146; ddd) Model Number DYNJ39408F, UDI/DI (EA) 10193489692839, UDI/DI (CS)40193489692830; eee) Model Number DYNJ39488G, UDI/DI (EA) 10193489383775, UDI/DI (CS)40193489383776; fff) Model Number DYNJ39889, UDI/DI (EA) 10884389796931, UDI/DI (CS)40884389796932; ggg) Model Number DYNJ40067G, UDI/DI (EA) 10195327244033, UDI/DI (CS)40195327244034; hhh) Model Number DYNJ40077F, UDI/DI (EA) 10195327175818, UDI/DI (CS)40195327175819; iii) Model Number DYNJ40108I, UDI/DI (EA) 10195327284183, UDI/DI (CS)40195327284184; jjj) Model Number DYNJ40215C, UDI/DI (EA) 10195327176501, UDI/DI (CS)40195327176502; kkk) Model Number DYNJ40379D, UDI/DI (EA) 10193489257618, UDI/DI (CS)40193489257619; lll) Model Number DYNJ41100C, UDI/DI (EA) 10193489899825, UDI/DI (CS)40193489899826; mmm) Model Number DYNJ41195D, UDI/DI (EA) 10193489314250, UDI/DI (CS)40193489314251; nnn) Model Number DYNJ42976, UDI/DI (EA) 10888277019140, UDI/DI (CS)40888277019141; ooo) Model Number DYNJ43085A, UDI/DI (EA) 10193489600346, UDI/DI (CS)40193489600347; ppp) Model Number DYNJ43922, UDI/DI (EA) 10888277074668, UDI/DI (CS)40888277074669; qqq) Model Number DYNJ44087B, UDI/DI (EA) 10195327346584, UDI/DI (CS)40195327346585; rrr) Model Number DYNJ44345F, UDI/DI (EA) 10889942966523, UDI/DI (CS)40889942966524; sss) Model Number DYNJ44345G, UDI/DI (EA) 10193489939507, UDI/DI (CS)40193489939508; ttt) Model Number DYNJ44421D, UDI/DI (EA) 10193489482638, UDI/DI (CS)40193489482639; uuu) Model Number DYNJ44737B, UDI/DI (EA) 10193489351712, UDI/DI (CS)40193489351713; vvv) Model Number DYNJ44808G, UDI/DI (EA) 10193489875850, UDI/DI (CS)40193489875851; www) Model Number DYNJ45074C, UDI/DI (EA) 10193489222678, UDI/DI (CS)40193489222679; xxx) Model Number DYNJ46246A, UDI/DI (EA) 10889942584963, UDI/DI (CS)40889942584964; yyy) Model Number DYNJ46359D, UDI/DI (EA) 10193489961379, UDI/DI (CS)40193489961370; zzz) Model Number DYNJ47138B, UDI/DI (EA) 10889942274215, UDI/DI (CS)40889942274216; aaaa) Model Number DYNJ47645C, UDI/DI (EA) 10195327355173, UDI/DI (CS)40195327355174; bbbb) Model Number DYNJ47660K, UDI/DI (EA) 10193489875737, UDI/DI (CS)40193489875738; cccc) Model Number DYNJ48365, UDI/DI (EA) 10888277594593, UDI/DI (CS)40888277594594; dddd) Model Number DYNJ48456C, UDI/DI (EA) 10195327015862, UDI/DI (CS)40195327015863; eeee) Model Number DYNJ48907F, UDI/DI (EA) 10889942529421, UDI/DI (CS)40889942529422; ffff) Model Number DYNJ49874, UDI/DI (EA) 10888277890602, UDI/DI (CS)40888277890603; gggg) Model Number DYNJ49931I, UDI/DI (EA) 10193489939217, UDI/DI (CS)40193489939218; hhhh) Model Number DYNJ49933I, UDI/DI (EA) 10193489471687, UDI/DI (CS)40193489471688; iiii) Model Number DYNJ49933J, UDI/DI (EA) 10195327065614, UDI/DI (CS)40195327065615; jjjj) Model Number DYNJ50227C, UDI/DI (EA) 10889942938612, UDI/DI (CS)40889942938613; kkkk) Model Number DYNJ50785, UDI/DI (EA) 10889942105304, UDI/DI (CS)40889942105305; llll) Model Number DYNJ51304C, UDI/DI (EA) 10193489460988, UDI/DI (CS)40193489460989; mmmm) Model Number DYNJ51925F, UDI/DI (EA) 10195327153397, UDI/DI (CS)40195327153398; nnnn) Model Number DYNJ52024, UDI/DI (EA) 10889942233359, UDI/DI (CS)40889942233350; oooo) Model Number DYNJ52056C, UDI/DI (EA) 10193489369441, UDI/DI (CS)40193489369442; pppp) Model Number DYNJ52056D, UDI/DI (EA) 10195327096137, UDI/DI (CS)40195327096138; qqqq) Model Number DYNJ52098, UDI/DI (EA) 10889942237067, UDI/DI (CS)40889942237068; rrrr) Model Number DYNJ52586A, UDI/DI (EA) 10193489494396, UDI/DI (CS)40193489494397; ssss) Model Number DYNJ52586B, UDI/DI (EA) 10195327212117, UDI/DI (CS)40195327212118; tttt) Model Number DYNJ52606F, UDI/DI (EA) 10193489343298, UDI/DI (CS)40193489343299; uuuu) Model Number DYNJ52756A, UDI/DI (EA) 10193489413830, UDI/DI (CS)40193489413831; vvvv) Model Number DYNJ52766A, UDI/DI (EA) 10193489292367, UDI/DI (CS)40193489292368; wwww) Model Number DYNJ53433F, UDI/DI (EA) 10193489328677, UDI/DI (CS)40193489328678; xxxx) Model Number DYNJ53433G, UDI/DI (EA) 10195327042431, UDI/DI (CS)40195327042432; yyyy) Model Number DYNJ53433I, UDI/DI (EA) 10195327074494, UDI/DI (CS)40195327074495; zzzz) Model Number DYNJ53433J, UDI/DI (EA) 10195327222925, UDI/DI (CS)40195327222926;
Recalling Firm/
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
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 172722 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.