Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL...
FDA Device Recall #Z-2199-2023 — Class II — May 18, 2023
Recall Summary
| Recall Number | Z-2199-2023 |
| 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 | 39391 units |
Product Description
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1005; b) 20GX6" FEMORAL ART LINE KIT, Model Number ART1165; c) 3" RADIAL ARTERIAL LINE KIT, Model Number ART240A; d) 6" FEMORAL ARTERIAL LINE KIT, Model Number ART245A; e) 6" FEMORAL ARTERIAL LINE KIT, Model Number ART245B; f) ARTERIAL LINE BUNDLE, Model Number ART255; g) ARTERIAL LINE BUNDLE, Model Number ART560; h) A LINE TRAY, Model Number ART690; i) ARTERIAL LINE TRAY, Model Number ART840; j) 18GX6" FEMORAL ART LINE KIT, Model Number ART960; k) 20Gx3" RADIAL ART LINE KIT, Model Number ART970; l) BIOPSY/ASPIRATION TRAY, Model Number BT235A; m) PERCUTANEOUS CHEST TUBE KIT, Model Number CHT1825; n) PICC INSERTION KIT, Model Number CVI3735; o) PICC INSERTION BUNDLE, Model Number CVI4025A; p) VASCULAR ACCESS INSERTION KIT, Model Number CVI4180; q) VASCULAR ACCESS INSERT KIT-PEDIATRICS, Model Number CVI4265; r) UNIVERSAL CVC ZONE DEFENSE BUNDLE, Model Number CVI4430; s) PEDIATRIC PICC INSERTION TRAY, Model Number CVI4450A; t) CVC ACCESSORY BUNDLE, Model Number CVI4505; u) DIALYSIS/CVC BUNDLE W/O CATHETER, Model Number CVI4655; v) FISHLINE KIT, Model Number CVI4725; w) VENOUS ACCESS TRAY, Model Number CVI4830A; x) VENOUS ACCESS TRAY, Model Number CVI4830B; y) CVC INSERTION BUNDLE- ADD A CATHETER, Model Number CVI4905; z) MVHS CVC LUMEN TRAY, Model Number CVI4920; aa) ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number DT22570A; bb) ADULT VASCULAR ACCESS BUNDLE, Model Number DT22860; cc) TOTE MCADAMS OSC SHLDR ARTHRO, Model Number DYKM1790A; dd) MAX BARRIER KIT, Model Number DYND2673B; ee) THYROID FNA TRAY, Model Number DYNDA2238A; ff) PARA/THORACENTESIS TRAY, Model Number DYNDH1470B; gg) BASIC BIOPSY TRAY, Model Number DYNDH1534; hh) ULTRASOUND BIOPSY, Model Number DYNDH1542; ii) BIOPSY TRAY, Model Number DYNDH1661; jj) USG PIV KIT, Model Number DYNDV2536A; kk) ULTRASOUND IV ACCESS PACK - LF, Model Number DYNJ0182378B; ll) PORT INSERTION KIT, Model Number MNS11590; mm) RADIOLOGY TRAY, Model Number MNS11625; nn) BEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number MNS12065; oo) INTRA PROBE COVER 5X96 KIT, Model Number P155598; pp) ULTRASOUND PROBE KIT, Model Number P482986; qq) ARTHROGRAM TRAY, Model Number SPEC0232; rr) ULTRA CORE BIOPSY KIT, Model Number SPEC0291B;
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 ART1005, UDI/DI (EA) 10193489198232, UDI/DI (CS) 20193489198239; b) Model Number ART1165, UDI/DI (EA) 10653160354680, UDI/DI (CS) 00653160354683; c) Model Number ART240A, UDI/DI (EA) 10653160328025, UDI/DI (CS) 00653160328028; d) Model Number ART245A, UDI/DI (EA) 10653160328018, UDI/DI (CS) 00653160328011; e) Model Number ART245B, UDI/DI (EA) 10653160358442, UDI/DI (CS) 00653160358445; f) Model Number ART255, UDI/DI (EA) 10653160311997, UDI/DI (CS) 00653160311990; g) Model Number ART560, UDI/DI (EA) 10653160310822, UDI/DI (CS) 00653160310825; h) Model Number ART690, UDI/DI (EA) 10653160318019, UDI/DI (CS) 00653160318012; i) Model Number ART840, UDI/DI (EA) 10653160322924, UDI/DI (CS) 00653160322927; j) Model Number ART960, UDI/DI (EA) 10193489190915, UDI/DI (CS) 20193489190912; k) Model Number ART970, UDI/DI (EA) 10193489190922, UDI/DI (CS) 20193489190929; l) Model Number BT235A, UDI/DI (EA) 10653160315919, UDI/DI (CS) 00653160315912; m) Model Number CHT1825, UDI/DI (EA) 10653160328988, UDI/DI (CS) 00653160328981; n) Model Number CVI3735, UDI/DI (EA) 10653160261544, UDI/DI (CS) 00653160261547; o) Model Number CVI4025A, UDI/DI (EA) 10193489396058, UDI/DI (CS) 40193489396059; p) Model Number CVI4180, UDI/DI (EA) 10653160284451, UDI/DI (CS) 00653160284454; q) Model Number CVI4265, UDI/DI (EA) 10653160291268, UDI/DI (CS) 00653160291261; r) Model Number CVI4430, UDI/DI (EA) 10653160314370, UDI/DI (CS) 00653160314373; s) Model Number CVI4450A, UDI/DI (EA) 10653160320517, UDI/DI (CS) 00653160320510; t) Model Number CVI4505, UDI/DI (EA) 10653160319047, UDI/DI (CS) 00653160319040; u) Model Number CVI4655, UDI/DI (EA) 10193489190373, UDI/DI (CS) 20193489190370; v) Model Number CVI4725, UDI/DI (EA) 10193489199871, UDI/DI (CS) 20193489199878; w) Model Number CVI4830A, UDI/DI (EA) 10653160353553, UDI/DI (CS) 00653160353556; x) Model Number CVI4830B, UDI/DI (EA) 10653160358534, UDI/DI (CS) 00653160358537; y) Model Number CVI4905, UDI/DI (EA) 10653160355618, UDI/DI (CS) 00653160355611; z) Model Number CVI4920, UDI/DI (EA) 10653160355847, UDI/DI (CS) 00653160355840; aa) Model Number DT22570A, UDI/DI (EA) 10653160346074, UDI/DI (CS) 00653160346077; bb) Model Number DT22860, UDI/DI (EA) 10653160359142, UDI/DI (CS) 00653160359145; cc) Model Number DYKM1790A, UDI/DI (EA) 10193489112412, UDI/DI (CS) 20193489112419; dd) Model Number DYND2673B, UDI/DI (EA) 10193489191394, UDI/DI (CS) 20193489191391; ee) Model Number DYNDA2238A, UDI/DI (EA) 10193489191554, UDI/DI (CS) 20193489191551; ff) Model Number DYNDH1470B, UDI/DI (EA) 10193489111248, UDI/DI (CS) 20193489111245; gg) Model Number DYNDH1534, UDI/DI (EA) 10193489197082, UDI/DI (CS) 20193489197089; hh) Model Number DYNDH1542, UDI/DI (EA) 10193489197396, UDI/DI (CS) 20193489197393; ii) Model Number DYNDH1661, UDI/DI (EA) 10193489111521, UDI/DI (CS) 20193489111528; jj) Model Number DYNDV2536A, UDI/DI (EA) 10653160357872, UDI/DI (CS) 00653160357875; kk) Model Number DYNJ0182378B, UDI/DI (EA) 10653160338536, UDI/DI (CS) 00653160338539; ll) Model Number MNS11590, UDI/DI (EA) 10653160321293, UDI/DI (CS) 00653160321296; mm) Model Number MNS11625, UDI/DI (EA) 10653160322139, UDI/DI (CS) 00653160322132; nn) Model Number MNS12065, UDI/DI (EA) 10653160331193, UDI/DI (CS) 00653160331196; oo) Model Number P155598, UDI/DI (EA) 10888277902237, UDI/DI (CS) 40888277902238; pp) Model Number P482986, UDI/DI (EA) 10888277903630, UDI/DI (CS) 40888277903631; qq) Model Number SPEC0232, UDI/DI (EA) 10888277507418, UDI/DI (CS) 40888277507419; rr) Model Number SPEC0291B, UDI/DI (EA) 10889942453054, UDI/DI (CS) 40889942453055;
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.