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-2167-2023
• Recall Event ID: 92466
• Product Classification: Central venous catheter tray - Product Code OFF
• Product: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; b) ART LINE KIT NO CATH, Model Number ARTNC145; c) CENTRAL LINE TRAY, Model Number CVI4705; d) CENTRAL LINE INSERTION PACK, Model Number CVI4805; e) ED CENTRAL LINE KIT, Model Number CVI4865; f) NO CATH MIDLINE INSERTION KIT, Model Number CVI4950A; g) CENTRAL LINE PROCEDURE KIT, Model Number DT22260; h) ADULT EPIV INSERTION TRAY, Model Number DYNDA2482; i) ULTRASOUND GUIDED PIV KIT, Model Number DYNDA2669; j) I.R. PICC PACK, Model Number DYNDA2759; k) IR SONO PACK, Model Number DYNDA3010; l) NEONATAL PICC LINE TRAY, Model Number DYNDC2120B; m) PICC SUPPLEMENTAL KIT, Model Number DYNDC2373A; n) CENTRAL LINE KIT, Model Number DYNDC2582A; o) CENTRAL LINE KIT UTMB, Model Number DYNDC3061; p) FNA TRAY, Model Number DYNDH1123B; q) CVL PACK, Model Number DYNJ00281O; r) CENTRAL VENOUS ACCESS PACK-LF, Model Number DYNJ0214541O; s) CENTRAL LINE PACK-LF, Model Number DYNJ0220136Q; t) PICC LINE PACK-LF, Model Number DYNJ0235859I; u) PICC LINE PACK-LF, Model Number DYNJ0235859J; v) PICC LINE PACK-LF, Model Number DYNJ0235859K; w) PICC LINE PACK, Model Number DYNJ04592K; x) PICC LINE PACK-LF, Model Number DYNJ0678523N; y) PICC LINE PACK-LF, Model Number DYNJ0855123N; z) PICC INSERTION PACK-LF, Model Number DYNJ0880659F; aa) PICC PACK-LF, Model Number DYNJ0940720D; bb) VENOUS ACCESS PACK-LF, Model Number DYNJ09895R; cc) PICC PACK-LF, Model Number DYNJ17086A; dd) VENOUS ACCESS TRAY, Model Number DYNJ20094L; ee) PICC LINE PACK-LF, Model Number DYNJ21575I; ff) CENTRAL LINE PACK, Model Number DYNJ30087C; gg) PICC LINE PACK, Model Number DYNJ30233C; hh) PICC PACK, Model Number DYNJ30566B; ii) CENTRAL LINE PLACEMENT PACK-LF, Model Number DYNJ32358G; jj) PICC TRAY, Model Number DYNJ33005F; kk) PICC TRAY, Model Number DYNJ33005G; ll) PICC LINE INSERTION TRAY, Model Number DYNJ34241; mm) PICC PACK-LF, Model Number DYNJ35000I; nn) PORT PACK, Model Number DYNJ35163C; oo) PICC TRAY-LF, Model Number DYNJ35272; pp) PICC LINE INSERTION PACK, Model Number DYNJ38868K; qq) PICC LINE INSERTION PACK, Model Number DYNJ38868L; rr) PICC ACCESSORY TRAY, Model Number DYNJ39039M; ss) CVC/PICC INSERTION PACK EH-LF, Model Number DYNJ40204B; tt) PICC INSERTION PACK MH-LF, Model Number DYNJ40206B; uu) ACCESS PICC PACK, Model Number DYNJ40682B; vv) PHOENIXVILLE VENOUS PICC TRAY, Model Number DYNJ40990C; ww) MV-IR-PICC PACK-LF, Model Number DYNJ41554C; xx) PICC TRAY, Model Number DYNJ41648; yy) CENTRAL LINE TRAY, Model Number DYNJ42902C; zz) CENTRAL LINE TRAY, Model Number DYNJ42902D; aaa) VENOUS PACK, Model Number DYNJ43168; bbb) VENOUS PACK, Model Number DYNJ43168A; ccc) VENOUS PACK, Model Number DYNJ43168B; ddd) IR CENTRAL VENOUS ACCESS, Model Number DYNJ43267G; eee) WEST VALLEY PICC LINE PACK, Model Number DYNJ43975A; fff) VENOUS LIGATION PACK, Model Number DYNJ43981G; ggg) VEIN CLOSURE TRAY - NIVC, Model Number DYNJ44737C; hhh) VENOUS ABLATION, Model Number DYNJ44904C; iii) PICC LINE PACK, Model Number DYNJ47037C; jjj) PICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717B; kkk) CENTRAL LINE PACK, Model Number DYNJ48096B; lll) PICC PACK-LF, Model Number DYNJ48120B; mmm) AV FISTULA PACK-LF, Model Number DYNJ48428C; nnn) VIEN CLOSURE, Model Number DYNJ49180A; ooo) ARTERIAL LINE PACK, Model Number DYNJ49235D; ppp) PICC PACK, Model Number DYNJ52255; qqq) PICC LINE TRAY, Model Number DYNJ52688B; rrr) PICC LINE TRAY, Model Number DYNJ52688C; sss) CENTRAL LINE INSERTION KIT, Model Number DYNJ52894A; ttt) ARTERIOGRAM PACK, Model Number DYNJ53095A; uuu) ENDOVENOUS ABLATION PACK, Model Number DYNJ53435D; vvv) MID HUDSON PICC LINE PACK, Model Number DYNJ53618A; www) MSB BEDSIDE TRAY, Model Number DYNJ54670; xxx) LEE VEIN PACK, Model Number DYNJ54906C; yyy) ARTERIOGRAM PACK, Model Number DYNJ55169G; zzz) PICC LINE PACK, Model Number DYNJ55170B; aaaa) PICC LINE PACK, M
• Code Information: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number ART995, UDI/DI (EA) 10193489190502,UDI/DI (CS) 40193489190503; b) Model Number ARTNC145, UDI/DI (EA) 10195327306762,UDI/DI (CS) 40195327306763; c) Model Number CVI4705, UDI/DI (EA) 10193489832372,UDI/DI (CS) 40193489832373; d) Model Number CVI4805, UDI/DI (EA) 10195327068714,UDI/DI (CS) 40195327068715; e) Model Number CVI4865, UDI/DI (EA) 10195327235260,UDI/DI (CS) 40195327235261; f) Model Number CVI4950A, UDI/DI (EA) 10195327351960,UDI/DI (CS) 40195327351961; g) Model Number DT22260, UDI/DI (EA) 10653160329190,UDI/DI (CS) 40653160329191; h) Model Number DYNDA2482, UDI/DI (EA) 10193489351606,UDI/DI (CS) 40193489351607; i) Model Number DYNDA2669, UDI/DI (EA) 10193489465426,UDI/DI (CS) 40193489465427; j) Model Number DYNDA2759, UDI/DI (EA) 10193489488197,UDI/DI (CS) 40193489488198; k) Model Number DYNDA3010, UDI/DI (EA) 10195327282301,UDI/DI (CS) 40195327282302; l) Model Number DYNDC2120B, UDI/DI (EA) 10193489363357,UDI/DI (CS) 40193489363358; m) Model Number DYNDC2373A, UDI/DI (EA) 10889942492206,UDI/DI (CS) 40889942492207; n) Model Number DYNDC2582A, UDI/DI (EA) 10193489349399,UDI/DI (CS) 40193489349390; o) Model Number DYNDC3061, UDI/DI (EA) 10193489495812,UDI/DI (CS) 40193489495813; p) Model Number DYNDH1123B, UDI/DI (EA) 10193489465556,UDI/DI (CS) 40193489465557; q) Model Number DYNJ00281O, UDI/DI (EA) 10193489962963,UDI/DI (CS) 40193489962964; r) Model Number DYNJ0214541O, UDI/DI (EA) 10195327088880,UDI/DI (CS) 40195327088881; s) Model Number DYNJ0220136Q, UDI/DI (EA) 10193489823486,UDI/DI (CS) 40193489823487; t) Model Number DYNJ0235859I, UDI/DI (EA) 10193489421347,UDI/DI (CS) 40193489421348; u) Model Number DYNJ0235859J, UDI/DI (EA) 10195327069278,UDI/DI (CS) 40195327069279; v) Model Number DYNJ0235859K, UDI/DI (EA) 10195327243210,UDI/DI (CS) 40195327243211; w) Model Number DYNJ04592K, UDI/DI (EA) 10193489215205,UDI/DI (CS) 40193489215206; x) Model Number DYNJ0678523N, UDI/DI (EA) 10193489994049,UDI/DI (CS) 40193489994040; y) Model Number DYNJ0855123N, UDI/DI (EA) 10195327094881,UDI/DI (CS) 40195327094882; z) Model Number DYNJ0880659F, UDI/DI (EA) 10195327111496,UDI/DI (CS) 40195327111497; aa) Model Number DYNJ0940720D, UDI/DI (EA) 10889942550951,UDI/DI (CS) 40889942550952; bb) Model Number DYNJ09895R, UDI/DI (EA) 10195327264529,UDI/DI (CS) 40195327264520; cc) Model Number DYNJ17086A, UDI/DI (EA) 10884389064306,UDI/DI (CS) 40884389064307; dd) Model Number DYNJ20094L, UDI/DI (EA) 10195327212902,UDI/DI (CS) 40195327212903; ee) Model Number DYNJ21575I, UDI/DI (EA) 10195327009670,UDI/DI (CS) 40195327009671; ff) Model Number DYNJ30087C, UDI/DI (EA) 10889942754144,UDI/DI (CS) 40889942754145; gg) Model Number DYNJ30233C, UDI/DI (EA) 10193489382570,UDI/DI (CS) 40193489382571; hh) Model Number DYNJ30566B, UDI/DI (EA) 10889942375523,UDI/DI (CS) 40889942375524; ii) Model Number DYNJ32358G, UDI/DI (EA) 10889942526475,UDI/DI (CS) 40889942526476; jj) Model Number DYNJ33005F, UDI/DI (EA) 10193489954135,UDI/DI (CS) 40193489954136; kk) Model Number DYNJ33005G, UDI/DI (EA) 10195327319663,UDI/DI (CS) 40195327319664; ll) Model Number DYNJ34241, UDI/DI (EA) 10884389335864,UDI/DI (CS) 40884389335865; mm) Model Number DYNJ35000I, UDI/DI (EA) 10193489261646,UDI/DI (CS) 40193489261647; nn) Model Number DYNJ35163C, UDI/DI (EA) 10889942494682,UDI/DI (CS) 40889942494683; oo) Model Number DYNJ35272, UDI/DI (EA) 10884389428269,UDI/DI (CS) 40884389428260; pp) Model Number DYNJ38868K, UDI/DI (EA) 10193489657609,UDI/DI (CS) 40193489657600; qq) Model Number DYNJ38868L, UDI/DI (EA) 10195327224776,UDI/DI (CS) 40195327224777; rr) Model Number DYNJ39039M, UDI/DI (EA) 10193489898507,UDI/DI (CS) 40193489898508; ss) Model Number DYNJ40204B, UDI/DI (EA) 10195327178451,UDI/DI (CS) 40195327178452; tt) Model Number DYNJ40206B, UDI/DI (EA) 10195327176440,UDI/DI (CS) 40195327176441; uu) Model Number DYNJ40682B, UDI/DI (EA) 10889942267217,UDI/DI (CS) 40889942267218; vv) Model Number DYNJ40990C, UDI/DI (EA) 10889942024377,UDI/DI (CS) 40889942024378; ww) Model Number DYNJ41554C, UDI/DI (EA) 10889942811328,UDI/DI (CS) 40889942811329; xx) Model Number DYNJ41648, UDI/DI (EA) 10884389909171,UDI/DI (CS) 40884389909172; yy) Model Number DYNJ42902C, UDI/DI (EA) 10195327084684,UDI/DI (CS) 40195327084685; zz) Model Number DYNJ42902D, UDI/DI (EA) 10195327171100,UDI/DI (CS) 40195327171101; aaa) Model Number DYNJ43168, UDI/DI (EA) 10888277034891,UDI/DI (CS) 40888277034892; bbb) Model Number DYNJ43168A, UDI/DI (EA) 10195327084707,UDI/DI (CS) 40195327084708; ccc) Model Number DYNJ43168B, UDI/DI (EA) 10195327224523,UDI/DI (CS) 40195327224524; ddd) Model Number DYNJ43267G, UDI/DI (EA) 10195327288808,UDI/DI (CS) 40195327288809; eee) Model Number DYNJ43975A, UDI/DI (EA) 10888277882447,UDI/DI (CS) 40888277882448; fff) Model Number DYNJ43981G, UDI/DI (EA) 10193489223538,UDI/DI (CS) 40193489223539; ggg) Model Number DYNJ44737C, UDI/DI (EA) 10195327277871,UDI/DI (CS) 40195327277872; hhh) Model Number DYNJ44904C, UDI/DI (EA) 10193489858679,UDI/DI (CS) 40193489858670; iii) Model Number DYNJ47037C, UDI/DI (EA) 10193489616002,UDI/DI (CS) 40193489616003; jjj) Model Number DYNJ47717B, UDI/DI (EA) 10195327355302,UDI/DI (CS) 40195327355303; kkk) Model Number DYNJ48096B, UDI/DI (EA) 10888277939318,UDI/DI (CS) 40888277939319; lll) Model Number DYNJ48120B, UDI/DI (EA) 10888277894877,UDI/DI (CS) 40888277894878; mmm) Model Number DYNJ48428C, UDI/DI (EA) 10193489702477,UDI/DI (CS) 40193489702478; nnn) Model Number DYNJ49180A, UDI/DI (EA) 10888277863569,UDI/DI (CS) 40888277863560; ooo) Model Number DYNJ49235D, UDI/DI (EA) 10193489894332,UDI/DI (CS) 40193489894333; ppp) Model Number DYNJ52255, UDI/DI (EA) 10889942253708,UDI/DI (CS) 40889942253709; qqq) Model Number DYNJ52688B, UDI/DI (EA) 10193489452471,UDI/DI (CS) 40193489452472; rrr) Model Number DYNJ52688C, UDI/DI (EA) 10195327301026,UDI/DI (CS) 40195327301027; sss) Model Number DYNJ52894A, UDI/DI (EA) 10889942437542,UDI/DI (CS) 40889942437543; ttt) Model Number DYNJ53095A, UDI/DI (EA) 10195327148720,UDI/DI (CS) 40195327148721; uuu) Model Number DYNJ53435D, UDI/DI (EA) 10195327196448,UDI/DI (CS) 40195327196449; vvv) Model Number DYNJ53618A, UDI/DI (EA) 10889942492497,UDI/DI (CS) 40889942492498; www) Model Number DYNJ54670, UDI/DI (EA) 10889942499571,UDI/DI (CS) 40889942499572; xxx) Model Number DYNJ54906C, UDI/DI (EA) 10195327188764,UDI/DI (CS) 40195327188765; yyy) Model Number DYNJ55169G, UDI/DI (EA) 10193489967562,UDI/DI (CS) 40193489967563; zzz) Model Number DYNJ55170B, UDI/DI (EA) 10193489967579,UDI/DI (CS) 40193489967570; aaaa) Model Number DYNJ55170C, UDI/DI (EA) 10195327135355,UDI/DI (CS) 40195327135356; bbbb) Model Number DYNJ55546D, UDI/DI (EA) 10195327056520,UDI/DI (CS) 40195327056521; cccc) Model Number DYNJ56029A, UDI/DI (EA) 10195327347826,UDI/DI (CS) 40195327347827; dddd) Model Number DYNJ56857C, UDI/DI (EA) 10193489967586,UDI/DI (CS) 40193489967587; eeee) Model Number DYNJ56857D, UDI/DI (EA) 10195327280963,UDI/DI (CS) 40195327280964; ffff) Model Number DYNJ57112, UDI/DI (EA) 10889942721597,UDI/DI (CS) 40889942721598; gggg) Model Number DYNJ57793A, UDI/DI (EA) 10193489846027,UDI/DI (CS) 40193489846028; hhhh) Model Number DYNJ59246A, UDI/DI (EA) 10195327039110,UDI/DI (CS) 40195327039111; iiii) Model Number DYNJ59751B, UDI/DI (EA) 10193489695915,UDI/DI (CS) 40193489695916; jjjj) Model Number DYNJ60038A, UDI/DI (EA) 10195327038335,UDI/DI (CS) 40195327038336; kkkk) Model Number DYNJ60329A, UDI/DI (EA) 10193489972221,UDI/DI (CS) 40193489972222; llll) Model Number DYNJ60990B, UDI/DI (EA) 10193489921700,UDI/DI (CS) 40193489921701; mmmm) Model Number DYNJ62038B, UDI/DI (EA) 10193489898491,UDI/DI (CS) 40193489898492; nnnn) Model Number DYNJ62711A, UDI/DI (EA) 10193489233018,UDI/DI (CS) 40193489233019; oooo) Model Number DYNJ62889A, UDI/DI (EA) 10193489971125,UDI/DI (CS) 40193489971126; pppp) Model Number DYNJ62889B, UDI/DI (EA) 10195327030957,UDI/DI (CS) 40195327030958; qqqq) Model Number DYNJ63162, UDI/DI (EA) 10193489720891,UDI/DI (CS) 40193489720892; rrrr) Model Number DYNJ63213, UDI/DI (EA) 10193489728217,UDI/DI (CS) 40193489728218; ssss) Model Number DYNJ63268C, UDI/DI (EA) 10195327077167,UDI/DI (CS) 40195327077168; tttt) Model Number DYNJ63268D, UDI/DI (EA) 10195327132217,UDI/DI (CS) 40195327132218; uuuu) Model Number DYNJ63268F, UDI/DI (EA) 10195327297114,UDI/DI (CS) 40195327297115; vvvv) Model Number DYNJ63590, UDI/DI (EA) 10193489769180,UDI/DI (CS) 40193489769181; wwww) Model Number DYNJ64141A, UDI/DI (EA) 10195327279578,UDI/DI (CS) 40195327279579; xxxx) Model Number DYNJ64190B, UDI/DI (EA) 10195327281281,UDI/DI (CS) 40195327281282; yyyy) Model Number DYNJ64249A, UDI/DI (EA) 10193489381368,UDI/DI (CS) 40193489381369; zzzz) Model Number DYNJ64337, UDI/DI (EA) 10193489800289,UDI/DI (CS) 40193489800280
• 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: 269985 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.