Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115; b) MAJOR VASCULAR, Model Number CDS980752I; c) PICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F; d) PICC LINE TRIPLE LUMEN CDS, Model Number CDS982859F; e) CHP TRANSPLANT CDS, Model Number CDS983082J; f) CLOSURE CDS, Model Number CDS983704I; g) MIDLINE INSERTION TRAY, Model Number CVI4340; h) PORT INSERTION PACK, Model Number CVI4765; i) MAX BARRIER KIT, Model Number DYND2673B; j) POWERGLIDE PLACEMENT KIT, Model Number DYNDA1468C; k) DEPIPPO PACK, Model Number DYNDA2011B; l) VEIN PROCEDURE KIT, Model Number DYNDA2076; m) SCLEROTHERAPY KIT, Model Number DYNDA2148A; n) IR SONO PACK, Model Number DYNDA2365B; o) ULTRASOUND BASIC KIT, Model Number DYNDC2099; p) PIV WITH ULTRASOUND KIT, Model Number DYNDC2399A; q) PARA THORACENTESIS TRAY, Model Number DYNDH1165A; r) ULTRASOUND TRAY, Model Number DYNDH1204; s) PARA/THORACENTESIS TRAY, Model Number DYNDH1292; t) ULTRASOUND GUIDE BREAST BIOPSY, Model Number DYNDH1319; u) PARA/THORACENTESIS TRAY, Model Number DYNDH1470B; v) PARA/THORACENTESIS TRAY, Model Number DYNDH1470C; w) US GUIDED LOC KIT, Model Number DYNDH1492; x) AMINO KIT, Model Number DYNDH1649; y) BREAST ULTRASOUND PROCEDURE TR, Model Number DYNDL1596A; z) ULTRASOUND GUIDED PIV KIT, Model Number DYNDV2038B; aa) ULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385A; bb) CVL PACK, Model Number DYNJ00281N; cc) FEM POP PACK, Model Number DYNJ01964M; dd) MAXIMUM BARRIER PACK-LF, Model Number DYNJ0248546D; ee) VEIN PACK, Model Number DYNJ0309084D; ff) DR. BAHDOUCH PACK, Model Number DYNJ0351069; gg) ANGIO STANDARD PACK-LF, Model Number DYNJ0370436Q; hh) SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535Y; ii) JUDKINS PACK-LF, Model Number DYNJ0530948AR; jj) JUDKINS PACK-LF, Model Number DYNJ0586030P; kk) SPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508Q; ll) MINI PACK-LF, Model Number DYNJ0604540P; mm) MINI PACK-LF, Model Number DYNJ0604540Q; nn) BIOPSY PACK-LF, Model Number DYNJ0747885F; oo) PERC PACK-LF, Model Number DYNJ0774759O; pp) PERC PACK-LF, Model Number DYNJ0774759P; qq) RR-SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0785821N; rr) RR-SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0785821O; ss) CLOSURE PACK-LF, Model Number DYNJ0807503M; tt) LINE PLACEMENT PACK-LF, Model Number DYNJ0931376F; uu) DENTAL PACK-LF, Model Number DYNJ0952428; vv) VENOUS ACCESS TRAY, Model Number DYNJ20094K; ww) DEPAUL IR DIALYSIS PACK, Model Number DYNJ31934D; xx) VEIN CLOSURE PACK, Model Number DYNJ32397B; yy) LARGE PROCEDURE PACK, Model Number DYNJ35524D; zz) RAD CVC TRAY, Model Number DYNJ35574A; aaa) WILDCAT BUNDLE KIT-ADULT, Model Number DYNJ35988J; bbb) WILDCAT BUNDLE KIT-PEDIATRIC, Model Number DYNJ35989G; ccc) STERILE PICC TRAY-LF, Model Number DYNJ36814B; ddd) PARA/THORA PACK, Model Number DYNJ37280C; eee) BASIC PACK, Model Number DYNJ37460A; fff) MINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326F; ggg) MINOR PROCEDURE PACK, Model Number DYNJ38563O; hhh) VEIN PACK, Model Number DYNJ38682C; iii) ADULT CVC MAX BARRIER KIT-LF, Model Number DYNJ38714B; jjj) PICC LINE INSERTION, Model Number DYNJ39885A; kkk) PEDIATRIC MAX BARRIER KIT-LF, Model Number DYNJ40306A; lll) HL VEIN STRIPPING PACK, Model Number DYNJ40374A; mmm) GENERAL USE PACK, Model Number DYNJ41137B; nnn) PICC LINE INSERTION WRO-LF, Model Number DYNJ41873B; ooo) CV ACCESS PACK WRO-LF, Model Number DYNJ41875B; ppp) RADIOLOGY PACK, Model Number DYNJ42172A; qqq) BASIC PACK, Model Number DYNJ42691; rrr) DRAINAGE TRAY, Model Number DYNJ42913; sss) DRAINAGE TRAY, Model Number DYNJ42913A; ttt) IR MINI KIT, Model Number DYNJ44519F; uuu) IR PERIPHERAL PACK, Model Number DYNJ45033A; vvv) EVLT CORE PACK, Model Number DYNJ45294; www) EVLT PACK, Model Number DYNJ45997C; xxx) PHLEBECTOMY PACK, Model Number DYNJ47502B; yyy) LINE KIT, Model Number DYNJ47987B; zzz) VEI
Hazard / Issue
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number ARTNC115, UDI/DI (EA) 10653160354338, UDI/DI (CS) 40653160354339; b) Model Number CDS980752I, UDI/DI (EA) 10889942428540, UDI/DI (CS) 40889942428541; c) Model Number CDS982858F, UDI/DI (EA) 10888277739215, UDI/DI (CS) 40888277739216; d) Model Number CDS982859F, UDI/DI (EA) 10888277739208, UDI/DI (CS) 40888277739209; e) Model Number CDS983082J, UDI/DI (EA) 10193489674514, UDI/DI (CS) 40193489674515; f) Model Number CDS983704I, UDI/DI (EA) 10193489854558, UDI/DI (CS) 40193489854559; g) Model Number CVI4340, UDI/DI (EA) 10653160309475, UDI/DI (CS) 40653160309476; h) Model Number CVI4765, UDI/DI (EA) 10193489953183, UDI/DI (CS) 40193489953184; i) Model Number DYND2673B, UDI/DI (EA) 10193489564358, UDI/DI (CS) 40193489564359; j) Model Number DYNDA1468C, UDI/DI (EA) 10889942843176, UDI/DI (CS) 40889942843177; k) Model Number DYNDA2011B, UDI/DI (EA) 10193489533026, UDI/DI (CS) 40193489533027; l) Model Number DYNDA2076, UDI/DI (EA) 10889942708505, UDI/DI (CS) 40889942708506; m) Model Number DYNDA2148A, UDI/DI (EA) 10888277734036, UDI/DI (CS) 40888277734037; n) Model Number DYNDA2365B, UDI/DI (EA) 10193489836448, UDI/DI (CS) 40193489836449; o) Model Number DYNDC2099, UDI/DI (EA) 10888277295674, UDI/DI (CS) 40888277295675; p) Model Number DYNDC2399A, UDI/DI (EA) 10889942446933, UDI/DI (CS) 40889942446934; q) Model Number DYNDH1165A, UDI/DI (EA) 10889942611508, UDI/DI (CS) 40889942611509; r) Model Number DYNDH1204, UDI/DI (EA) 10889942519835, UDI/DI (CS) 40889942519836; s) Model Number DYNDH1292, UDI/DI (EA) 10889942742233, UDI/DI (CS) 40889942742234; t) Model Number DYNDH1319, UDI/DI (EA) 10889942795475, UDI/DI (CS) 40889942795476; u) Model Number DYNDH1470B, UDI/DI (EA) 10193489111248, UDI/DI (CS) 40193489111249; v) Model Number DYNDH1470C, UDI/DI (EA) 10195327297718, UDI/DI (CS) 40195327297719; w) Model Number DYNDH1492, UDI/DI (EA) 10193489434460, UDI/DI (CS) 40193489434461; x) Model Number DYNDH1649, UDI/DI (EA) 10193489944365, UDI/DI (CS) 40193489944366; y) Model Number DYNDL1596A, UDI/DI (EA) 10884389926505, UDI/DI (CS) 40884389926506; z) Model Number DYNDV2038B, UDI/DI (EA) 10193489919837, UDI/DI (CS) 40193489919838; aa) Model Number DYNDV2385A, UDI/DI (EA) 10195327298760, UDI/DI (CS) 40195327298761; bb) Model Number DYNJ00281N, UDI/DI (EA) 10193489449808, UDI/DI (CS) 40193489449809; cc) Model Number DYNJ01964M, UDI/DI (EA) 10193489648034, UDI/DI (CS) 40193489648035; dd) Model Number DYNJ0248546D, UDI/DI (EA) 10195327069285, UDI/DI (CS) 40195327069286; ee) Model Number DYNJ0309084D, UDI/DI (EA) 10889942885268, UDI/DI (CS) 40889942885269; ff) Model Number DYNJ0351069, UDI/DI (EA) 10889942059058, UDI/DI (CS) 40889942059059; gg) Model Number DYNJ0370436Q, UDI/DI (EA) 10888277779280, UDI/DI (CS) 40888277779281; hh) Model Number DYNJ0416535Y, UDI/DI (EA) 10193489994056, UDI/DI (CS) 40193489994057; ii) Model Number DYNJ0530948AR, UDI/DI (EA) 10195327141882, UDI/DI (CS) 40195327141883; jj) Model Number DYNJ0586030P, UDI/DI (EA) 10889942947140, UDI/DI (CS) 40889942947141; kk) Model Number DYNJ0604508Q, UDI/DI (EA) 10193489560190, UDI/DI (CS) 40193489560191; ll) Model Number DYNJ0604540P, UDI/DI (EA) 10193489560206, UDI/DI (CS) 40193489560207; mm) Model Number DYNJ0604540Q, UDI/DI (EA) 10193489839685, UDI/DI (CS) 40193489839686; nn) Model Number DYNJ0747885F, UDI/DI (EA) 10193489542318, UDI/DI (CS) 40193489542319; oo) Model Number DYNJ0774759O, UDI/DI (EA) 10195327091859, UDI/DI (CS) 40195327091850; pp) Model Number DYNJ0774759P, UDI/DI (EA) 10195327246136, UDI/DI (CS) 40195327246137; qq) Model Number DYNJ0785821N, UDI/DI (EA) 10193489915792, UDI/DI (CS) 40193489915793; rr) Model Number DYNJ0785821O, UDI/DI (EA) 10195327263737, UDI/DI (CS) 40195327263738; ss) Model Number DYNJ0807503M, UDI/DI (EA) 10889942091737, UDI/DI (CS) 40889942091738; tt) Model Number DYNJ0931376F, UDI/DI (EA) 10193489271508, UDI/DI (CS) 40193489271509; uu) Model Number DYNJ0952428, UDI/DI (EA) 10889942101610, UDI/DI (CS) 40889942101611; vv) Model Number DYNJ20094K, UDI/DI (EA) 10193489213256, UDI/DI (CS) 40193489213257; ww) Model Number DYNJ31934D, UDI/DI (EA) 10195327071509, UDI/DI (CS) 40195327071500; xx) Model Number DYNJ32397B, UDI/DI (EA) 10884389916650, UDI/DI (CS) 40884389916651; yy) Model Number DYNJ35524D, UDI/DI (EA) 10193489766103, UDI/DI (CS) 40193489766104; zz) Model Number DYNJ35574A, UDI/DI (EA) 10884389538067, UDI/DI (CS) 40884389538068; aaa) Model Number DYNJ35988J, UDI/DI (EA) 10195327024666, UDI/DI (CS) 40195327024667; bbb) Model Number DYNJ35989G, UDI/DI (EA) 10195327024673, UDI/DI (CS) 40195327024674; ccc) Model Number DYNJ36814B, UDI/DI (EA) 10195327075576, UDI/DI (CS) 40195327075577; ddd) Model Number DYNJ37280C, UDI/DI (EA) 10889942431656, UDI/DI (CS) 40889942431657; eee) Model Number DYNJ37460A, UDI/DI (EA) 10888277560437, UDI/DI (CS) 40888277560438; fff) Model Number DYNJ38326F, UDI/DI (EA) 10193489236675, UDI/DI (CS) 40193489236676; ggg) Model Number DYNJ38563O, UDI/DI (EA) 10193489251746, UDI/DI (CS) 40193489251747; hhh) Model Number DYNJ38682C, UDI/DI (EA) 10889942897193, UDI/DI (CS) 40889942897194; iii) Model Number DYNJ38714B, UDI/DI (EA) 10889942601936, UDI/DI (CS) 40889942601937; jjj) Model Number DYNJ39885A, UDI/DI (EA) 10889942539932, UDI/DI (CS) 40889942539933; kkk) Model Number DYNJ40306A, UDI/DI (EA) 10889942601929, UDI/DI (CS) 40889942601920; lll) Model Number DYNJ40374A, UDI/DI (EA) 10888277557949, UDI/DI (CS) 40888277557940; mmm) Model Number DYNJ41137B, UDI/DI (EA) 10889942260874, UDI/DI (CS) 40889942260875; nnn) Model Number DYNJ41873B, UDI/DI (EA) 10193489563061, UDI/DI (CS) 40193489563062; ooo) Model Number DYNJ41875B, UDI/DI (EA) 10193489563078, UDI/DI (CS) 40193489563079; ppp) Model Number DYNJ42172A, UDI/DI (EA) 10193489502718, UDI/DI (CS) 40193489502719; qqq) Model Number DYNJ42691, UDI/DI (EA) 10888277003507, UDI/DI (CS) 40888277003508; rrr) Model Number DYNJ42913, UDI/DI (EA) 10888277013209, UDI/DI (CS) 40888277013200; sss) Model Number DYNJ42913A, UDI/DI (EA) 10195327080600, UDI/DI (CS) 40195327080601; ttt) Model Number DYNJ44519F, UDI/DI (EA) 10193489467475, UDI/DI (CS) 40193489467476; uuu) Model Number DYNJ45033A, UDI/DI (EA) 10193489475807, UDI/DI (CS) 40193489475808; vvv) Model Number DYNJ45294, UDI/DI (EA) 10888277098978, UDI/DI (CS) 40888277098979; www) Model Number DYNJ45997C, UDI/DI (EA) 10889942684366, UDI/DI (CS) 40889942684367; xxx) Model Number DYNJ47502B, UDI/DI (EA) 10193489649222, UDI/DI (CS) 40193489649223; yyy) Model Number DYNJ47987B, UDI/DI (EA) 10193489867374, UDI/DI (CS) 40193489867375; zzz) Model Number DYNJ48454, UDI/DI (EA) 10888277595286, UDI/DI (CS) 40888277595287; aaaa) Model Number DYNJ48456B, UDI/DI (EA) 10889942733170, UDI/DI (CS) 40889942733171; bbbb) Model Number DYNJ49177F, UDI/DI (EA) 10888277774346, UDI/DI (CS) 40888277774347; cccc) Model Number DYNJ49737C, UDI/DI (EA) 10195327235888, UDI/DI (CS) 40195327235889; dddd) Model Number DYNJ51248B, UDI/DI (EA) 10889942873401, UDI/DI (CS) 40889942873402; eeee) Model Number DYNJ51340D, UDI/DI (EA) 10193489569810, UDI/DI (CS) 40193489569811; ffff) Model Number DYNJ51638C, UDI/DI (EA) 10195327039561, UDI/DI (CS) 40195327039562; gggg) Model Number DYNJ51705B, UDI/DI (EA) 10193489877175, UDI/DI (CS) 40193489877176; hhhh) Model Number DYNJ52122B, UDI/DI (EA) 10193489935301, UDI/DI (CS) 40193489935302; iiii) Model Number DYNJ52122C, UDI/DI (EA) 10195327260088, UDI/DI (CS) 40195327260089; jjjj) Model Number DYNJ52171, UDI/DI (EA) 10889942243471, UDI/DI (CS) 40889942243472; kkkk) Model Number DYNJ53122B, UDI/DI (EA) 10193489321227, UDI/DI (CS) 40193489321228; llll) Model Number DYNJ53135C, UDI/DI (EA) 10193489468434, UDI/DI (CS) 40193489468435; mmmm) Model Number DYNJ53319C, UDI/DI (EA) 10193489634495, UDI/DI (CS) 40193489634496; nnnn) Model Number DYNJ53435C, UDI/DI (EA) 10193489200867, UDI/DI (CS) 40193489200868; oooo) Model Number DYNJ53482A, UDI/DI (EA) 10889942917310, UDI/DI (CS) 40889942917311; pppp) Model Number DYNJ53658A, UDI/DI (EA) 10889942684403, UDI/DI (CS) 40889942684404; qqqq) Model Number DYNJ54131, UDI/DI (EA) 10889942466801, UDI/DI (CS) 40889942466802; rrrr) Model Number DYNJ54265, UDI/DI (EA) 10889942474004, UDI/DI (CS) 40889942474005; ssss) Model Number DYNJ54437C, UDI/DI (EA) 10193489243970, UDI/DI (CS) 40193489243971; tttt) Model Number DYNJ54569A, UDI/DI (EA) 10193489742954, UDI/DI (CS) 40193489742955; uuuu) Model Number DYNJ54894A, UDI/DI (EA) 10193489213553, UDI/DI (CS) 40193489213554; vvvv) Model Number DYNJ55063A, UDI/DI (EA) 10193489680546, UDI/DI (CS) 40193489680547; wwww) Model Number DYNJ55456, UDI/DI (EA) 10889942548446, UDI/DI (CS) 40889942548447; xxxx) Model Number DYNJ55457, UDI/DI (EA) 10889942548460, UDI/DI (CS) 40889942548461; yyyy) Model Number DYNJ55458, UDI/DI (EA) 10889942548453, UDI/DI (CS) 40889942548454; zzzz) Model Number DYNJ55723A, UDI/DI (EA) 10889942865536, UDI/DI (CS) 40889942865537