Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START…
Medical device recall Z-2200-2023. Published in FDA’s Enforcement Report on Jul 26, 2023.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 26, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 70648 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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;
70648 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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)…
Every code shown here, 2,000 characters
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…
FDA’s list runs to 2,900 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 18, 2023.
- FDA classified it on Jul 20, 2023.
- FDA’s Enforcement Report published it on Jul 26, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- MEDLINE INDUSTRIES, LP - Northfield, of Northfield, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,900 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.