Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX C...
FDA Device Recall #Z-2194-2023 — Class II — May 18, 2023
Recall Summary
| Recall Number | Z-2194-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 18, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 10080 units |
Product Description
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE, Model Number ECVC1320; b) CENTRAL VENOUS CATH INSERTION BUNDLE PI, Model Number ECVC1345A; c) TRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1490A; d) TRIPLE LUMEN CVC INSERTION TRAY, Model Number ECVC1495A; e) CENTRAL VENOUS CATHETER BNDLE KIT, Model Number ECVC1725; f) INTRODUCER/INTROFLEX BUNDLE KIT (P/S), Model Number ECVC1915; g) 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC1970B; h) CVC BUNDLE KIT 20CM, Model Number ECVC2001; i) 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number ECVC2205A; j) CVC BUNDLE KIT 16CM, Model Number ECVC2240A; k) FIRST HEALTH 16CM QUAD LUMEN KIT, Model Number ECVC2320; l) 7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC2440B; m) 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2555; n) 20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number ECVC2560; o) FIRST HEALTH 20CM QUAD LUMEN TRAY, Model Number ECVC2720; p) CENTRAL LINE BUNDLE W/7F, 16CM, 3L, Model Number ECVC2745; q) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number ECVC2750; r) 7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number ECVC2770; s) CVC INSERT BUNDLE 16CM TRIPLE LUMEN, Model Number ECVC2895; t) SHEATH INTRODUCER BUNDLE, Model Number ECVC2930; u) DUAL INSERTION CVC + SHEATH BUNDLE, Model Number ECVC2940; v) TRIPLE LUMEN BUNDLE, Model Number ECVC2965; w) TRIPLE LUMEN BUNDLE, Model Number ECVC3155; x) CVC INSERTION BUNDLE 3L 20 CM VANTEX, Model Number ECVC3285A; y) CVC INSERTION BUNDLE 3L 16CM VANTEX, Model Number ECVC3286; z) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3355; aa) TRIPLE LUMEN BUNDLE, 20CM, Model Number ECVC3395; bb) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3460; cc) 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number ECVC3505; dd) 7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number ECVC3545; ee) TRIPLE LUMEN CVC INSERT BNDL 20CM, Model Number ECVC3735A; ff) CVC INS BUNDLE W/ MICROPUNCTURE KIT, Model Number ECVC3755A; gg) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC3785; hh) MULTI-LUMEN CVC INSERTION BUNDLE, Model Number ECVC3900; ii) QUAD LUMEN CVC INSERTION BUNDLE, Model Number ECVC4135; jj) AVA HIGH FLOW BUNDLE, Model Number ECVC4300; kk) 20CM 7F CVC INSERTION TRAY, Model Number ECVC4335; ll) OLEAN GENERAL CVC BUNDLE, Model Number ECVC4615; mm) 3L 7FR 16CM CVC INSERTION BUNDLE, Model Number ECVC4635A; nn) 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number ECVC4640A; oo) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC4880; pp) DUAL INSERT BUNDLE, 2L CVC + SHEATH, Model Number ECVC4985; qq) QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number ECVC4995; rr) 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number ECVC5010A; ss) TRIPLE LUMEN BUNDLE W/MULTIMED CATH, Model Number ECVC5015; tt) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020; uu) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5020A; vv) VANTEX CVC BUNDLE, 7 FR 3L 16CM, Model Number ECVC5080; ww) 20CM 3L 7FR CVC INSERTION BUNDLE, Model Number ECVC5135B; xx) TRIPLE LUMEN COMPLETE CATH KIT, Model Number ECVC5200; yy) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number ECVC5270; zz) CVC INSERTION BUNDLE - VANTEX, Model Number ECVC5310; aaa) CVC INSERTION BUNDLE - MULTIMED, Model Number ECVC5315; bbb) TRIPLE LUMEN CVC BUNDLE, Model Number ECVC5355B; ccc) CVC ZONE DEFENSE BUNDLE, Model Number ECVC5385; ddd) TRIPLE LUMEN BUNDLE, Model Number ECVC5475; eee) 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number ECVC5480; fff) CVC INSERTION MAX BUNDLE 20CM, Model Number ECVC5525A; ggg) CNTRL VENOUS CATH. INSERTION BNDL P/I, Model Number ECVC5530A; hhh) CVC BUNDLE TRIPLE LUMEN 16CM, Model Number ECVC5540A; iii) CVC INSERTION BUNDLE 3L, 7FR, 16CM, Model Number ECVC5560A; jjj) CVC DOUBLE LUMEN 16CM, Model Number ECVC5585B; kkk) CVC TRIPLE LUMEN 16CM, Model Number ECVC5590B; lll) PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number ECVC5650;
Reason for Recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Distribution Pattern
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Lot / Code Information
All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model number ECVC1320: UDI/DI (EA) 10653160335795, UDI/DI (CS) 00653160335798; b) Model number ECVC1345A: UDI/DI (EA) 10653160334606, UDI/DI (CS) 00653160334609; c) Model number ECVC1490A: UDI/DI (EA) 10653160359036, UDI/DI (CS) 00653160359039; d) Model number ECVC1495A: UDI/DI (EA) 10653160358794, UDI/DI (CS) 00653160358797; e) Model number ECVC1725: UDI/DI (EA) 10653160334507, UDI/DI (CS) 00653160334500; f) Model number ECVC1915: UDI/DI (EA) 10653160334446, UDI/DI (CS) 00653160334449; g) Model number ECVC1970B: UDI/DI (EA) 10653160357155, UDI/DI (CS) 00653160357158; h) Model number ECVC2001: UDI/DI (EA) 10653160334415, UDI/DI (CS) 00653160334418; i) Model number ECVC2205A: UDI/DI (EA) 10653160357148, UDI/DI (CS) 00653160357141; j) Model number ECVC2240A: UDI/DI (EA) 10653160334361, UDI/DI (CS) 00653160334364; k) Model number ECVC2320: UDI/DI (EA) 10653160332480, UDI/DI (CS) 00653160332483; l) Model number ECVC2440B: UDI/DI (EA) 10653160358930, UDI/DI (CS) 00653160358933; m) Model number ECVC2555: UDI/DI (EA) 10653160336570, UDI/DI (CS) 00653160336573; n) Model number ECVC2560: UDI/DI (EA) 10653160334286, UDI/DI (CS) 00653160334289; o) Model number ECVC2720: UDI/DI (EA) 10653160332657, UDI/DI (CS) 00653160332650; p) Model number ECVC2745: UDI/DI (EA) 10653160334224, UDI/DI (CS) 00653160334227; q) Model number ECVC2750: UDI/DI (EA) 10653160334217, UDI/DI (CS) 00653160334210; r) Model number ECVC2770: UDI/DI (EA) 10653160332671, UDI/DI (CS) 00653160332674; s) Model number ECVC2895: UDI/DI (EA) 10653160332725, UDI/DI (CS) 00653160332728; t) Model number ECVC2930: UDI/DI (EA) 10653160335368, UDI/DI (CS) 00653160335361; u) Model number ECVC2940: UDI/DI (EA) 10653160335351, UDI/DI (CS) 00653160335354; v) Model number ECVC2965: UDI/DI (EA) 10653160338611, UDI/DI (CS) 00653160338614; w) Model number ECVC3155: UDI/DI (EA) 10653160334132, UDI/DI (CS) 00653160334135; x) Model number ECVC3285A: UDI/DI (EA) 10653160358572, UDI/DI (CS) 00653160358575; y) Model number ECVC3286: UDI/DI (EA) 10653160358398, UDI/DI (CS) 00653160358391; z) Model number ECVC3355: UDI/DI (EA) 10653160333982, UDI/DI (CS) 00653160333985; aa) Model number ECVC3395: UDI/DI (EA) 10653160338635, UDI/DI (CS) 00653160338638; bb) Model number ECVC3460: UDI/DI (EA) 10653160332794, UDI/DI (CS) 00653160332797; cc) Model number ECVC3505: UDI/DI (EA) 10653160334767, UDI/DI (CS) 00653160334760; dd) Model number ECVC3545: UDI/DI (EA) 10653160334774, UDI/DI (CS) 00653160334777; ee) Model number ECVC3735A: UDI/DI (EA) 10653160334798, UDI/DI (CS) 00653160334791; ff) Model number ECVC3755A: UDI/DI (EA) 10653160334804, UDI/DI (CS) 00653160334807; gg) Model number ECVC3785: UDI/DI (EA) 10653160336006, UDI/DI (CS) 00653160336009; hh) Model number ECVC3900: UDI/DI (EA) 10653160334828, UDI/DI (CS) 00653160334821; ii) Model number ECVC4135: UDI/DI (EA) 10653160335900, UDI/DI (CS) 00653160335903; jj) Model number ECVC4300: UDI/DI (EA) 10653160334873, UDI/DI (CS) 00653160334876; kk) Model number ECVC4335: UDI/DI (EA) 10653160357285, UDI/DI (CS) 00653160357288; ll) Model number ECVC4615: UDI/DI (EA) 10653160336075, UDI/DI (CS) 00653160336078; mm) Model number ECVC4635A: UDI/DI (EA) 10653160352112, UDI/DI (CS) 00653160352115; nn) Model number ECVC4640A: UDI/DI (EA) 10653160352105, UDI/DI (CS) 00653160352108; oo) Model number ECVC4880: UDI/DI (EA) 10653160333111, UDI/DI (CS) 00653160333114; pp) Model number ECVC4985: UDI/DI (EA) 10653160335269, UDI/DI (CS) 00653160335262; qq) Model number ECVC4995: UDI/DI (EA) 10653160335283, UDI/DI (CS) 00653160335286; rr) Model number ECVC5010A: UDI/DI (EA) 10653160335290, UDI/DI (CS) 00653160335293; ss) Model number ECVC5015: UDI/DI (EA) 10653160338956, UDI/DI (CS) 00653160338959; tt) Model number ECVC5020: UDI/DI (EA) 10653160334903, UDI/DI (CS) 00653160334906; uu) Model number ECVC5020A: UDI/DI (EA) 10653160358251, UDI/DI (CS) 00653160358254; vv) Model number ECVC5080: UDI/DI (EA) 10653160337690, UDI/DI (CS) 00653160337693; ww) Model number ECVC5135B: UDI/DI (EA) 10653160353652, UDI/DI (CS) 00653160353655; xx) Model number ECVC5200: UDI/DI (EA) 10653160336150, UDI/DI (CS) 00653160336153; yy) Model number ECVC5270: UDI/DI (EA) 10653160336198, UDI/DI (CS) 00653160336191; zz) Model number ECVC5310: UDI/DI (EA) 10653160336211, UDI/DI (CS) 00653160336214; aaa) Model number ECVC5315: UDI/DI (EA) 10653160339465, UDI/DI (CS) 00653160339468; bbb) Model number ECVC5355B: UDI/DI (EA) 10653160357742, UDI/DI (CS) 00653160357745; ccc) Model number ECVC5385: UDI/DI (EA) 10653160336518, UDI/DI (CS) 00653160336511; ddd) Model number ECVC5475: UDI/DI (EA) 10653160338116, UDI/DI (CS) 00653160338119; eee) Model number ECVC5480: UDI/DI (EA) 10653160339458, UDI/DI (CS) 00653160339451; fff) Model number ECVC5525A: UDI/DI (EA) 10653160338130, UDI/DI (CS) 00653160338133; ggg) Model number ECVC5530A: UDI/DI (EA) 10653160345596, UDI/DI (CS) 00653160345599; hhh) Model number ECVC5540A: UDI/DI (EA) 10653160335009, UDI/DI (CS) 00653160335002; iii) Model number ECVC5560A: UDI/DI (EA) 10653160336501, UDI/DI (CS) 00653160336504; jjj) Model number ECVC5585B: UDI/DI (EA) 10653160357711, UDI/DI (CS) 00653160357714; kkk) Model number ECVC5590B: UDI/DI (EA) 10653160357728, UDI/DI (CS) 00653160357721; lll) Model number ECVC5650: UDI/DI (EA) 10653160336457, UDI/DI (CS) 00653160336450; mmm) Model number ECVC5655: UDI/DI (EA) 10653160337621, UDI/DI (CS) 00653160337624; nnn) Model number ECVC5660: UDI/DI (EA) 10653160337638, UDI/DI (CS) 00653160337631; ooo) Model number ECVC5665: UDI/DI (EA) 10653160341505, UDI/DI (CS) 00653160341508; ppp) Model number ECVC5810: UDI/DI (EA) 10653160336419, UDI/DI (CS) 00653160336412; qqq) Model number ECVC5815: UDI/DI (EA) 10653160336402, UDI/DI (CS) 00653160336405; rrr) Model number ECVC5855B: UDI/DI (EA) 10653160355113, UDI/DI (CS) 00653160355116; sss) Model number ECVC5870A: UDI/DI (EA) 10653160338383, UDI/DI (CS) 00653160338386; ttt) Model number ECVC5985B: UDI/DI (EA) 10653160357797, UDI/DI (CS) 00653160357790; uuu) Model number ECVC6015B: UDI/DI (EA) 10653160357704, UDI/DI (CS) 00653160357707; vvv) Model number ECVC6070: UDI/DI (EA) 10653160335863, UDI/DI (CS) 00653160335866; www) Model number ECVC6075: UDI/DI (EA) 10653160338437, UDI/DI (CS) 00653160338430; xxx) Model number ECVC6120: UDI/DI (EA) 10653160336532, UDI/DI (CS) 00653160336535; yyy) Model number ECVC6255: UDI/DI (EA) 10653160336525, UDI/DI (CS) 00653160336528; zzz) Model number ECVC6260: UDI/DI (EA) 10653160336488, UDI/DI (CS) 00653160336481; aaaa) Model number ECVC6265: UDI/DI (EA) 10653160342922, UDI/DI (CS) 00653160342925; bbbb) Model number ECVC6340A: UDI/DI (EA) 10653160355038, UDI/DI (CS) 00653160355031; cccc) Model number ECVC6355: UDI/DI (EA) 10653160336396, UDI/DI (CS) 00653160336399; dddd) Model number ECVC6370: UDI/DI (EA) 10653160333425, UDI/DI (CS) 00653160333428; eeee) Model number ECVC6490A: UDI/DI (EA) 10653160344360, UDI/DI (CS) 00653160344363; ffff) Model number ECVC6505: UDI/DI (EA) 10653160336327, UDI/DI (CS) 00653160336320; gggg) Model number ECVC6540: UDI/DI (EA) 10653160339397, UDI/DI (CS) 00653160339390; hhhh) Model number ECVC6550: UDI/DI (EA) 10653160335276, UDI/DI (CS) 00653160335279; iiii) Model number ECVC6555: UDI/DI (EA) 10653160336341, UDI/DI (CS) 00653160336344; jjjj) Model number ECVC6585A: UDI/DI (EA) 10653160338826, UDI/DI (CS) 00653160338829; kkkk) Model number ECVC6595: UDI/DI (EA) 10653160337485, UDI/DI (CS) 00653160337488; llll) Model number ECVC6655A: UDI/DI (EA) 10653160339267, UDI/DI (CS) 00653160339260; mmmm) Model number ECVC6680A: UDI/DI (EA) 10653160337164, UDI/DI (CS) 00653160337167; nnnn) Model number ECVC6690: UDI/DI (EA) 10653160336600, UDI/DI (CS) 00653160336603; oooo) Model number ECVC6765: UDI/DI (EA) 10653160336839, UDI/DI (CS) 00653160336832; pppp) Model number ECVC6800: UDI/DI (EA) 10653160335092, UDI/DI (CS) 00653160335095; qqqq) Model number ECVC6800A: UDI/DI (EA) 10653160355694, UDI/DI (CS) 00653160355697; rrrr) Model number ECVC6815: UDI/DI (EA) 10653160335115, UDI/DI (CS) 00653160335118; ssss) Model number ECVC6825A: UDI/DI (EA) 10653160336631, UDI/DI (CS) 00653160336634; tttt) Model number ECVC6835: UDI/DI (EA) 10653160336778, UDI/DI (CS) 00653160336771; uuuu) Model number ECVC6840: UDI/DI (EA) 10653160336761, UDI/DI (CS) 00653160336764; vvvv) Model number ECVC6845: UDI/DI (EA) 10653160339366, UDI/DI (CS) 00653160339369; wwww) Model number ECVC6850: UDI/DI (EA) 10653160338819, UDI/DI (CS) 00653160338812; xxxx) Model number ECVC6915: UDI/DI (EA) 10653160336723, UDI/DI (CS) 00653160336726; yyyy) Model number ECVC6920: UDI/DI (EA) 10653160336716, UDI/DI (CS) 00653160336719; zzzz) Model number ECVC6970: UDI/DI (EA) 10653160336693, UDI/DI (CS) 00653160336696
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.