Class II FDA device recall · Z-2200-2023

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) ARTERIAL LINE START KIT , Model Number ART920; b) ULTRASOUND GUIDED PIV KIT , Model Number BSIPIV1005; c) ULTRASOUND GUIDED IV START KIT W/SHIELD , Model Number BSIPIV1006; d) PIV BSI KIT , Model Number BSIPIV1010; e) ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG , Model Number BSIPIV1011; f) PICC INSERTION TRAY , Model Number CVI3805; g) PEDIATRIC PICC INSERTION TRAY , Model Number CVI4450B; h) CENTRAL LINE INSERTION TRAY , Model Number DT19810; i) NEONATAL PICC INSERTION TRAY , Model Number DYNDA2509A; j) USG PIV KIT , Model Number DYNDV2536; k) ULTRASOUND GUIDED IV START KIT , Model Number DYNDV2547; l) USG PIV KIT , Model Number DYNDV2567; m) POLY MIDLINE KIT 4F SL , Model Number DYNJ68937A; n) PICC KIT 4F SL PL MAX BARRIER , Model Number DYNJ70141MB; o) PICC KIT 5F DL PL MB , Model Number DYNJ70152MB; p) MIDLINE KIT 4F SL PL MAX BARR , Model Number DYNJ80141MB; q) MIDLINE KIT 5F DL PL MAX BARR , Model Number DYNJ80152MB; r) ULTRASOUND GUIDED PIV KIT , Model Number IVS3420B; s) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3635C; t) FLOOR ULTRASOUND GUIDED IV SECUREMENT , Model Number IVS3770; u) ULTRASOUND GUIDED PIV KIT , Model Number IVS3900A; v) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940A; w) ULTRASOUND GUIDED PIV INSERTION KIT , Model Number IVS3940B; x) ULTRASOUND GUIDED PIV KIT , Model Number IVS4005; y) MIDLINE KIT 4F SL MB , Model Number MID0001; z) MIDLINE KIT 4F SL PL MAX BARR , Model Number MID0003; aa) MIDLINE BUNDLE 4FR SL , Model Number MID0005; bb) MIDLINE KIT 4F SL PL MB , Model Number PICC0009A; cc) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0010; dd) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0011; ee) PICC KIT 4F SL PL MAX BARRIER , Model Number PICC0012; ff) PICC BUNDLE 5FR DL , Model Number PICC0013; gg) VANTEX 7FR 3L 20CM CVC INSERTION BNDL , Model Number STCVC2015A; hh) VANTEX 7FR 3L 16CM CVC INSERTION BNDL , Model Number STCVC2020A;

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 ART920, UDI/DI (EA) 10653160327899, UDI/DI (CS) 00653160327892;  b) Model Number BSIPIV1005, UDI/DI (EA) 10193489198867, UDI/DI (CS) 20193489198864;  c) Model Number BSIPIV1006, UDI/DI (EA) 10653160356936, UDI/DI (CS) 00653160356939;  d) Model Number BSIPIV1010, UDI/DI (EA) 10653160356523, UDI/DI (CS) 00653160356526;  e) Model Number BSIPIV1011, UDI/DI (EA) 10653160353317, UDI/DI (CS) 00653160353310;  f) Model Number CVI3805, UDI/DI (EA) 10653160265085, UDI/DI (CS) 00653160265088;  g) Model Number CVI4450B, UDI/DI (EA) 10653160358428, UDI/DI (CS) 00653160358421;  h) Model Number DT19810, UDI/DI (EA) 10653160285656, UDI/DI (CS) 00653160285659;  i) Model Number DYNDA2509A, UDI/DI (EA) 10193489196986, UDI/DI (CS) 20193489196983;  j) Model Number DYNDV2536, UDI/DI (EA) 10653160353676, UDI/DI (CS) 00653160353679;  k) Model Number DYNDV2547, UDI/DI (EA) 10653160354246, UDI/DI (CS) 00653160354249;  l) Model Number DYNDV2567, UDI/DI (EA) 10653160356455, UDI/DI (CS) 00653160356458;  m) Model Number DYNJ68937A, UDI/DI (EA) 10193489111545, UDI/DI (CS) 20193489111542;  n) Model Number DYNJ70141MB, UDI/DI (EA) 10889942722808, UDI/DI (CS) 20889942722805;  o) Model Number DYNJ70152MB, UDI/DI (EA) 10889942722822, UDI/DI (CS) 40889942722823;  p) Model Number DYNJ80141MB, UDI/DI (EA) 10889942733415, UDI/DI (CS) 20889942733412;  q) Model Number DYNJ80152MB, UDI/DI (EA) 10889942733422, UDI/DI (CS) 20889942733429;  r) Model Number IVS3420B, UDI/DI (EA) 10653160359067, UDI/DI (CS) 00653160359060;  s) Model Number IVS3635C, UDI/DI (EA) 10653160358954, UDI/DI (CS) 00653160358957;  t) Model Number IVS3770, UDI/DI (EA) 10653160328230, UDI/DI (CS) 00653160328233;  u) Model Number IVS3900A, UDI/DI (EA) 10653160347774, UDI/DI (CS) 00653160347777;  v) Model Number IVS3940A, UDI/DI (EA) 10653160345664, UDI/DI (CS) 00653160345667;  w) Model Number IVS3940B, UDI/DI (EA) 10653160355335, UDI/DI (CS) 00653160355338;  x) Model Number IVS4005, UDI/DI (EA) 10653160346142, UDI/DI (CS) 00653160346145;  y) Model Number MID0001, UDI/DI (EA) 10193489381627, UDI/DI (CS) 40193489381628;  z) Model Number MID0003, UDI/DI (EA) 10653160349334, UDI/DI (CS) 00653160349337;  aa) Model Number MID0005, UDI/DI (EA) 10653160349181, UDI/DI (CS) 00653160349184;  bb) Model Number PICC0009A, UDI/DI (EA) 10193489760231, UDI/DI (CS) 20193489760238;  cc) Model Number PICC0010, UDI/DI (EA) 10653160349112, UDI/DI (CS) 00653160349115;  dd) Model Number PICC0011, UDI/DI (EA) 10653160350842, UDI/DI (CS) 00653160350845;  ee) Model Number PICC0012, UDI/DI (EA) 10653160350491, UDI/DI (CS) 00653160350494;  ff) Model Number PICC0013, UDI/DI (EA) 10653160351818, UDI/DI (CS) 00653160351811;  gg) Model Number STCVC2015A, UDI/DI (EA) 10653160350552, UDI/DI (CS) 00653160350555;  hh) Model Number STCVC2020A, UDI/DI (EA) 10653160350569, UDI/DI (CS) 00653160350562

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-2200-2023
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-2200-2023 · Source: openFDA enforcement.