Class II FDA device recall · Z-2199-2023

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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;

Why it was recalled

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed 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;

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-2199-2023
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Northfield, IL
Recall initiated: 2023-05-18

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2199-2023 · Source: openFDA enforcement.