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-2168-2023
• 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) PORT PACK, Model Number DYNJ64675; b) PICC LINE TRAY, Model Number DYNJ64725B; c) VEIN OHH, Model Number DYNJ65560C; d) PORT PICC TUNNEL PACK, Model Number DYNJ65775; e) ENSEMBLE POWER PICC-HEJ-LF, Model Number DYNJ65827; f) PICC PACK, Model Number DYNJ65838; g) JVL-PACK PICC, Model Number DYNJ66062; h) FISTULAGRAM PACK, Model Number DYNJ66259; i) VEIN PACK-LF, Model Number DYNJ66271B; j) VEIN PACK-LF, Model Number DYNJ66271D; k) VASCULAR PACK, Model Number DYNJ66356F; l) VENOUS PACK, Model Number DYNJ66499A; m) VENOUS PACK, Model Number DYNJ66499B; n) VEIN PACK, Model Number DYNJ66743B; o) AV FISTULA PACK, Model Number DYNJ66916; p) VEIN ABLATION PLUS W CHL, Model Number DYNJ67115A; q) PICC INSERTION TRAY, Model Number DYNJ67415; r) AFCH CVC INSERTION, Model Number DYNJ67534; s) ENS PICC LINE-HEJ-LF, Model Number DYNJ67606; t) VEIN TRAY, Model Number DYNJ69012A; u) PICC PACK, Model Number DYNJ69088; v) PICC PACK, Model Number DYNJ69088A; w) VEIN PACK, Model Number DYNJ69091A; x) VEIN PACK, Model Number DYNJ69091B; y) VEIN PACK, Model Number DYNJ69177; z) VEIN ABLATION KIT, Model Number DYNJ69272; aa) VEIN ABLATION PACK, Model Number DYNJ69288; bb) BASIC VEIN PACK, Model Number DYNJ69426; cc) VASCULAR VEIN PACK, Model Number DYNJ69769; dd) BCH VEIN ABLATION, Model Number DYNJ69796; ee) VEIN PACK, Model Number DYNJ69942A; ff) FISTULA SAVANNAH PACK, Model Number DYNJ69943; gg) VEIN CLOSURE PACK, Model Number DYNJ69976; hh) VEIN CLOSURE PACK, Model Number DYNJ69976A; ii) VENCLOSE PROCEDURE PACK, Model Number DYNJ80123; jj) VENOUS PACK, Model Number DYNJ80169; kk) VENOUS PACK, Model Number DYNJ80169A; ll) CVR ENDOVENOUS PACK, Model Number DYNJ80643; mm) VENOUS PACK, Model Number DYNJ80692; nn) VENOUS PACK, Model Number DYNJ80692A; oo) VEIN PACK, Model Number DYNJ81120; pp) VEIN PROCEDURE PACK, Model Number DYNJ81177; qq) VEIN PACK, Model Number DYNJ81212A; rr) SUPERFICIAL VENOUS PROCEDURE, Model Number DYNJ81267; ss) OR VASCULAR ANGIO PACK, Model Number DYNJ81592; tt) PARAGON VEIN PACK, Model Number DYNJ81669; uu) PARAGON VEIN PACK, Model Number DYNJ81669B; vv) ANGIOGRAM-DECH-LF, Model Number DYNJ81725; ww) PICC-DECH-LF, Model Number DYNJ81726; xx) VEIN CLOSURE PACK, Model Number DYNJ81834; yy) VEIN PACK, Model Number DYNJ82033; zz) VEIN PACK, Model Number DYNJ82033A; aaa) SUPERFICIAL VENOUS PACK, Model Number DYNJ82100; bbb) SUPERFICIAL V2 PROCEDURE PK, Model Number DYNJ82101; ccc) VEIN PROCEDURE TRAY, Model Number DYNJ82581; ddd) VARICOSE VEIN PACK, Model Number DYNJ82884; eee) VARICOSE VEIN PACK, Model Number DYNJ82885; fff) LASER VEIN EC PACK, Model Number DYNJ82951; ggg) SUPERFICAL VENOUS PROCEDURE, Model Number DYNJ82989; hhh) PORT DIALYSIS PACK, Model Number DYNJ83087; iii) DEXMED ACCESS PACK, Model Number DYNJ83148; jjj) VEIN TRAY, Model Number DYNJ83384A; kkk) RADIO VEIN ABLATION PACK, Model Number DYNJ83534; lll) VEIN PACK, Model Number DYNJ83747; mmm) VEIN ABLATION PACK, Model Number DYNJ83846; nnn) VEIN PACK, Model Number DYNJ83914; ooo) VEIN PACK, Model Number DYNJ83935; ppp) VEIN ABLATION PACK, Model Number DYNJ83974; qqq) VENOUS ACCESS PORT INSERTION, Model Number DYNJ902602I; rrr) VASCULAR ACCESS-LF, Model Number DYNJ905285D; sss) GENERAL AV FISTULA, Model Number DYNJ906011B; ttt) KIT VEIN ABLATION, Model Number DYNJ907381; uuu) OPEN VASCULAR UE, Model Number DYNJ907858; vvv) PICC LINE TRAY-LF, Model Number DYNJT2272J; www) PICC LINE TRAY-LF, Model Number DYNJT2272K; xxx) PICC CUSTOM PACK, Model Number GSS584Q; yyy) ULTASOUND GUIDED PIV INSERTION, Model Number IVS3635A; zzz) PEDS/ NICU LINE KIT, Model Number MNS13555; aaaa) ER CENTRAL LINE KIT, Model Number P155508D; bbbb) PICC INSERTION TRAY, Model Number PICC0018; cccc) PICC TRAY, Model Number PICCNC0008; dddd) PQ PICC LINE PACK, Model Number PICCNC0013; eeee) STANDARD PICC II-LF, Model Number
• Code Information: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ64675, UDI/DI (EA) 10193489212143,UDI/DI (CS) 40193489212144; b) Model Number DYNJ64725B, UDI/DI (EA) 10193489452846,UDI/DI (CS) 40193489452847; c) Model Number DYNJ65560C, UDI/DI (EA) 10195327136819,UDI/DI (CS) 40195327136810; d) Model Number DYNJ65775, UDI/DI (EA) 10193489289824,UDI/DI (CS) 40193489289825; e) Model Number DYNJ65827, UDI/DI (EA) 10193489298499,UDI/DI (CS) 40193489298490; f) Model Number DYNJ65838, UDI/DI (EA) 10193489303261,UDI/DI (CS) 40193489303262; g) Model Number DYNJ66062, UDI/DI (EA) 10193489319217,UDI/DI (CS) 40193489319218; h) Model Number DYNJ66259, UDI/DI (EA) 10193489325485,UDI/DI (CS) 40193489325486; i) Model Number DYNJ66271B, UDI/DI (EA) 10193489998917,UDI/DI (CS) 40193489998918; j) Model Number DYNJ66271D, UDI/DI (EA) 10195327130749,UDI/DI (CS) 40195327130740; k) Model Number DYNJ66356F, UDI/DI (EA) 10195327160012,UDI/DI (CS) 40195327160013; l) Model Number DYNJ66499A, UDI/DI (EA) 10193489977523,UDI/DI (CS) 40193489977524; m) Model Number DYNJ66499B, UDI/DI (EA) 10195327242107,UDI/DI (CS) 40195327242108; n) Model Number DYNJ66743B, UDI/DI (EA) 10193489949797,UDI/DI (CS) 40193489949798; o) Model Number DYNJ66916, UDI/DI (EA) 10193489387650,UDI/DI (CS) 40193489387651; p) Model Number DYNJ67115A, UDI/DI (EA) 10195327091880,UDI/DI (CS) 40195327091881; q) Model Number DYNJ67415, UDI/DI (EA) 10193489930887,UDI/DI (CS) 40193489930888; r) Model Number DYNJ67534, UDI/DI (EA) 10193489409321,UDI/DI (CS) 40193489409322; s) Model Number DYNJ67606, UDI/DI (EA) 10193489421675,UDI/DI (CS) 40193489421676; t) Model Number DYNJ69012A, UDI/DI (EA) 10195327331719,UDI/DI (CS) 40195327331710; u) Model Number DYNJ69088, UDI/DI (EA) 10193489883619,UDI/DI (CS) 40193489883610; v) Model Number DYNJ69088A, UDI/DI (EA) 10193489975246,UDI/DI (CS) 40193489975247; w) Model Number DYNJ69091A, UDI/DI (EA) 10193489969764,UDI/DI (CS) 40193489969765; x) Model Number DYNJ69091B, UDI/DI (EA) 10195327178994,UDI/DI (CS) 40195327178995; y) Model Number DYNJ69177, UDI/DI (EA) 10193489902198,UDI/DI (CS) 40193489902199; z) Model Number DYNJ69272, UDI/DI (EA) 10193489920338,UDI/DI (CS) 40193489920339; aa) Model Number DYNJ69288, UDI/DI (EA) 10193489922677,UDI/DI (CS) 40193489922678; bb) Model Number DYNJ69426, UDI/DI (EA) 10193489939392,UDI/DI (CS) 40193489939393; cc) Model Number DYNJ69769, UDI/DI (EA) 10193489977790,UDI/DI (CS) 40193489977791; dd) Model Number DYNJ69796, UDI/DI (EA) 10193489979350,UDI/DI (CS) 40193489979351; ee) Model Number DYNJ69942A, UDI/DI (EA) 10195327284626,UDI/DI (CS) 40195327284627; ff) Model Number DYNJ69943, UDI/DI (EA) 10193489998443,UDI/DI (CS) 40193489998444; gg) Model Number DYNJ69976, UDI/DI (EA) 10195327001308,UDI/DI (CS) 40195327001309; hh) Model Number DYNJ69976A, UDI/DI (EA) 10195327130398,UDI/DI (CS) 40195327130399; ii) Model Number DYNJ80123, UDI/DI (EA) 10195327009182,UDI/DI (CS) 40195327009183; jj) Model Number DYNJ80169, UDI/DI (EA) 10195327013448,UDI/DI (CS) 40195327013449; kk) Model Number DYNJ80169A, UDI/DI (EA) 10195327169749,UDI/DI (CS) 40195327169740; ll) Model Number DYNJ80643, UDI/DI (EA) 10195327055790,UDI/DI (CS) 40195327055791; mm) Model Number DYNJ80692, UDI/DI (EA) 10195327065546,UDI/DI (CS) 40195327065547; nn) Model Number DYNJ80692A, UDI/DI (EA) 10195327340827,UDI/DI (CS) 40195327340828; oo) Model Number DYNJ81120, UDI/DI (EA) 10195327085889,UDI/DI (CS) 40195327085880; pp) Model Number DYNJ81177, UDI/DI (EA) 10195327089610,UDI/DI (CS) 40195327089611; qq) Model Number DYNJ81212A, UDI/DI (EA) 10195327159863,UDI/DI (CS) 40195327159864; rr) Model Number DYNJ81267, UDI/DI (EA) 10195327101442,UDI/DI (CS) 40195327101443; ss) Model Number DYNJ81592, UDI/DI (EA) 10195327123772,UDI/DI (CS) 40195327123773; tt) Model Number DYNJ81669, UDI/DI (EA) 10195327132323,UDI/DI (CS) 40195327132324; uu) Model Number DYNJ81669B, UDI/DI (EA) 10195327253431,UDI/DI (CS) 40195327253432; vv) Model Number DYNJ81725, UDI/DI (EA) 10195327136758,UDI/DI (CS) 40195327136759; ww) Model Number DYNJ81726, UDI/DI (EA) 10195327136772,UDI/DI (CS) 40195327136773; xx) Model Number DYNJ81834, UDI/DI (EA) 10195327147853,UDI/DI (CS) 40195327147854; yy) Model Number DYNJ82033, UDI/DI (EA) 10195327162979,UDI/DI (CS) 40195327162970; zz) Model Number DYNJ82033A, UDI/DI (EA) 10195327271442,UDI/DI (CS) 40195327271443; aaa) Model Number DYNJ82100, UDI/DI (EA) 10195327170592,UDI/DI (CS) 40195327170593; bbb) Model Number DYNJ82101, UDI/DI (EA) 10195327170585,UDI/DI (CS) 40195327170586; ccc) Model Number DYNJ82581, UDI/DI (EA) 10195327198657,UDI/DI (CS) 40195327198658; ddd) Model Number DYNJ82884, UDI/DI (EA) 10195327215996,UDI/DI (CS) 40195327215997; eee) Model Number DYNJ82885, UDI/DI (EA) 10195327216009,UDI/DI (CS) 40195327216000; fff) Model Number DYNJ82951, UDI/DI (EA) 10195327218973,UDI/DI (CS) 40195327218974; ggg) Model Number DYNJ82989, UDI/DI (EA) 10195327221768,UDI/DI (CS) 40195327221769; hhh) Model Number DYNJ83087, UDI/DI (EA) 10195327231255,UDI/DI (CS) 40195327231256; iii) Model Number DYNJ83148, UDI/DI (EA) 10195327235512,UDI/DI (CS) 40195327235513; jjj) Model Number DYNJ83384A, UDI/DI (EA) 10195327304812,UDI/DI (CS) 40195327304813; kkk) Model Number DYNJ83534, UDI/DI (EA) 10195327276713,UDI/DI (CS) 40195327276714; lll) Model Number DYNJ83747, UDI/DI (EA) 10195327300739,UDI/DI (CS) 40195327300730; mmm) Model Number DYNJ83846, UDI/DI (EA) 10195327311490,UDI/DI (CS) 40195327311491; nnn) Model Number DYNJ83914, UDI/DI (EA) 10195327313128,UDI/DI (CS) 40195327313129; ooo) Model Number DYNJ83935, UDI/DI (EA) 10195327318543,UDI/DI (CS) 40195327318544; ppp) Model Number DYNJ83974, UDI/DI (EA) 10195327323141,UDI/DI (CS) 40195327323142; qqq) Model Number DYNJ902602I, UDI/DI (EA) 10193489892567,UDI/DI (CS) 40193489892568; rrr) Model Number DYNJ905285D, UDI/DI (EA) 10195327062668,UDI/DI (CS) 40195327062669; sss) Model Number DYNJ906011B, UDI/DI (EA) 10193489411232,UDI/DI (CS) 40193489411233; ttt) Model Number DYNJ907381, UDI/DI (EA) 10193489900774,UDI/DI (CS) 40193489900775; uuu) Model Number DYNJ907858, UDI/DI (EA) 10193489909357,UDI/DI (CS) 40193489909358; vvv) Model Number DYNJT2272J, UDI/DI (EA) 10889942426324,UDI/DI (CS) 40889942426325; www) Model Number DYNJT2272K, UDI/DI (EA) 10195327250676,UDI/DI (CS) 40195327250677; xxx) Model Number GSS584Q, UDI/DI (EA) 10193489941029,UDI/DI (CS) 40193489941020; yyy) Model Number IVS3635A, UDI/DI (EA) 10193489362916,UDI/DI (CS) 40193489362917; zzz) Model Number MNS13555, UDI/DI (EA) 10653160991953,UDI/DI (CS) 40653160991954; aaaa) Model Number P155508D, UDI/DI (EA) 10193489899061,UDI/DI (CS) 40193489899062; bbbb) Model Number PICC0018, UDI/DI (EA) 10195327327392,UDI/DI (CS) 40195327327393; cccc) Model Number PICCNC0008, UDI/DI (EA) 10195327221584,UDI/DI (CS) 40195327221585; dddd) Model Number PICCNC0013, UDI/DI (EA) 10195327311223,UDI/DI (CS) 40195327311224; eeee) Model Number PICCNC002, UDI/DI (EA) 10193489877199,UDI/DI (CS) 40193489877190; ffff) Model Number VC-PP-6F12, UDI/DI (EA) 10193489576658,UDI/DI (CS) 40193489576659; gggg) Model Number VC-PPH-6F12A, UDI/DI (EA) 10193489423105,UDI/DI (CS) 40193489423106; hhhh) Model Number VC-PPH-6F7A, UDI/DI (EA) 10193489423099,UDI/DI (CS) 40193489423090; iiii) Model Number VC-PPM-12F, UDI/DI (EA) 10193489422689,UDI/DI (CS) 40193489422680
• 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: # included in 3,740,814 units 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.