Hearth Record

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel

Medical device recall Z-2322-2023. Published in FDA’s Enforcement Report on Aug 9, 2023.

FDA’s own record, on accessdata.fda.gov

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 Aug 9, 2023. Copied from openFDA on Oct 20, 2026.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6” FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3” RADIAL ART LINE KIT, Model Number: ART970; c. 20GX6” FEMORAL ART LINE KIT, Model Number: ART1165; d. 3” RADIAL ARTERIAL LINE KIT, Model Number: ART240A; e. 6” FEMORAL ARTERIAL LINE KIT, Model Number: ART245A, ART245B; f. A LINE TRAY, Model Number: ART690; g. A-LINE INSERTION TRAY, Model Number: ART645; h. AMNIOCENTESIS TRAY, Model Number: MNS8750; i. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570A; j. ART LINE TRAY, Model Number: ART865; k. ARTERIAL LINE BUNDLE, Model Number: ART255, ART560; l. ARTERIAL LINE TRAY, Model Number: ART840; m. ARTHROGRAM TRAY, Model Number: SPEC0232; n. BASIC BIOPSY TRAY, Model Number: DYNDH1534; o. BEDSIDE PIGTAIL THORACOSTOMY PROCEDURE, Model Number: MNS12065; p. BEDSIDE PROCEDURE PREP KIT, Model Number: MNS7695A; q. BIOPSY TRAY, Model Number: DYNDH1661, MNS8705; r. BIOPSY/ASPIRATION TRAY, Model Number: BT235A; s. BRST BX Tray, Model Number: DYNDH1389A; t. CATHETER PREP KIT, Model Number: DYNDC2638, DYNDC2638A; u. CENTRAL LINE INSERTION KIT, Model Number: DT15975; v. CENTRAL LINE PROCEDURE KIT, Model Number: DT22260; w. CHEST TUBE INSERTION TRAY, Model Number: TRICHT1120; x. CONTINUOUS NERVE BLOCK PREP KIT, Model Number: MNS6660; y. CVC ACCESSORY BUNDLE, Model Number: CVI4505; z. CVC INFANT INSERTION PACK, Model Number: CVI4770; aa. CVC INSERTION BUNDLE, Model Number: CVI3940; bb. CVC INSERTION BUNDLE- ADD A CATHETER, Model Number: CVI4905; cc. CVL INSERTION TRAY, Model Number: DYNDC1786A; dd. DIAGNOSTIC PROCEDURE TRAY, Model Number: DYNJRA0585; ee. DIALYSIS CATHETER INSERTION KIT, Model Number: CVI4050; ff. DIALYSIS/CVC BUNDLE W/O CATHETER, Model Number: CVI4655; gg. EXTREMITY PACK, Model Number: CVI4680; hh. FEMORAL ARTERIAL LINE BUNDLE, Model Number: ART1005; ii. FEMORAL ARTERIAL LINE TRAY, Model Number: ART945; jj. FISHLINE KIT, Model Number: CVI4725; kk. FNA TRAY, Model Number: DYNDH1123B; ll. GENERAL ASPIRATION TRAY - CHOICE, Model Number: DYNDH1397; mm. HEMODIALYSIS ACCESS KIT, Model Number: DT12970; nn. IMPLANT ACCESSORY PACK, Model Number: MNS12955; oo. MAX BARRIER ART LINE KIT, Model Number: ART950; pp. MAX BARRIER KIT, Model Number: DYND2673B; qq. MIDLINE INSERTION, Model Number: DYNDC2890; rr. MINOR PROCEDURE TRAY, Model Number: DYNDA2418; ss. MULTI-PURPOSE SPECIALS TRAY, Model Number: MNS8565; tt. MVHS CVC LUMEN TRAY, Model Number: CVI4920; uu. NECK BIOPSY KIT, Model Number: DYNDH1449A; vv. NERVE BLOCK TRAY, Model Number: MNS8315; ww. PARA/THORACENTESIS TRAY, Model Number: DYNDH1292, DYNDH1470, DYNDH1470A, DYNDH1470B; xx. PEDI ULTRASOUND GUIDED PIV KIT, Model Number: IVS3320; yy. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450A; zz. PEDIATRIC ULTRASOUND KIT, Model Number: MNS12995A; aaa. PERCUTANEOUS CHEST TUBE KIT, Model Number: CHT1825; bbb. PERM CATH KIT, Model Number: MNS10755; ccc. PICC INSERTION BUNDLE, Model Number: CVI3830, CVI4025, CVI4025A; ddd. PICC INSERTION BUNDLE (P/S), Model Number: CVI4025; eee. PICC INSERTION KIT, Model Number: CVI3735, CVI4615; fff. PICC SUPPLEMENTAL KIT, Model Number: DYNDC2373A; ggg. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A; hhh. PORT INSERTION KIT, Model Number: MNS11590; iii. PPE BUNDLE KIT, Model Number: DT13351A; jjj. RADIOLOGY TRAY, Model Number: MNS11625; kkk. SCLEROTHERAPY KIT, Model Number: DYNDA2148A; lll. THYROID BIOPSY TRAY-CHOICE, Model Number: DYNDA2446; mmm. THYROID FNA TRAY, Model Number: DYNDA2238, DNDA2238A. nnn. TOTE MCADAMS OSC SHLDR ARTHRO, Model Number: DYKM1790A; ooo. TREATMENT PACK, Model Number: TPO71922-3; ppp. U/S CORE BIOPSY KIT, Model Number: DYNDH1121C; qqq

134,514 kits, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: ART960, UPC Number: 10193489190915. b. Model Number: ART970, UPC Number: 10193489190922. c. Model…

Every code shown here, 1,993 characters

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: ART960, UPC Number: 10193489190915. b. Model Number: ART970, UPC Number: 10193489190922. c. Model Number: ART1165, UPC Number: 10653160354680. d. Model Number: ART240A, UPC Number: 10653160328025. e. Model Number: ART245A, UPC Number: 10653160328018; Model Number: ART245B, UPC Number: 10653160358442. f. Model Number: ART690, UPC Number: 10653160318019. g. Model Number: ART645, UPC Number: 10653160314394. h. Model Number: MNS8750, UPC Number: 065316027073. i. Model Number: DT22570A, UPC Number: 10653160346074. j. Model Number: ART865, UPC Number: 10653160325062. k. Model Number: ART255, UPC Number: 10653160311997; Model Number: ART560, UPC Number: 10653160310822. l. Model Number: ART840, UPC Number: 10653160322924. m. Model Number: SPEC0232, UPC Number: 10888277507418. n. Model Number: DYNDH1534, UPC Number: 10193489197082. o. Model Number: MNS12065, UPC Number: 10653160331193. p. Model Number: MNS7695A, UPC Number: 10653160343455. q. Model Number: DYNDH1661, UPC Number: 10193489111521; Model Number: MNS8705, UPC Number: 10653160267508. r. Model Number: BT235A, UPC Number: 10653160315919. s. Model Number: DYNDH1389A, UPC Number: 10193489193510. t. Model Number: DYNDC2638, UPC Number: 10889942786428; Model Number: DYNDC2638A, UPC Number: 10193489782813. u. Model Number: DT15975, UPC Number: 065316025244. v. Model Number: DT22260, UPC Number: 10653160329190. w. Model Number: TRICHT1120, UPC Number: 10653160318293. x. Model Number: MNS6660, UPC Number: 00653160223477. y. Model Number: CVI4505, UPC Number: 10653160319047. z. Model Number: CVI4770, UPC Number: 10193489111262. aa. Model Number: CVI3940, UPC Number: 065316027297. bb. Model Number: CVI4905, UPC Number: 10653160355618. cc. Model Number: DYNDC1786A, UPC Number: 10193489199116. dd. Model Number: DYNJRA0585, UPC Number: 10888277580695. ee. Model Number: CVI4050, UPC…

FDA’s list runs to 5,839 characters. The first part is shown; the rest is on FDA’s record.

Source:

Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.

Barcodes and drug codes

  • UPC 10193489190915
  • UPC 10193489190922
  • UPC 10653160354680
  • UPC 10653160328025
  • UPC 10653160328018
  • UPC 10653160358442
  • UPC 10653160318019
  • UPC 10653160314394
  • UPC 065316027073
  • UPC 10653160346074
  • UPC 10653160325062
  • UPC 10653160311997
  • UPC 10653160310822
  • UPC 10653160322924
  • UPC 10888277507418
  • UPC 10193489197082
  • UPC 10653160331193
  • UPC 10653160343455
  • UPC 10193489111521
  • UPC 10653160267508
  • UPC 10653160315919
  • UPC 10193489193510
  • UPC 10889942786428
  • UPC 10193489782813
  • UPC 065316025244
  • UPC 10653160329190
  • UPC 10653160318293
  • UPC 00653160223477
  • UPC 10653160319047
  • UPC 10193489111262
  • UPC 065316027297
  • UPC 10653160355618
  • UPC 10193489199116
  • UPC 10888277580695
  • UPC 10653160278894
  • UPC 10193489190373
  • UPC 10193489198492
  • UPC 10193489198232
  • UPC 10653160330165
  • UPC 10193489199871
  • UPC 10193489193312
  • UPC 10888277733206
  • UPC 00653160223712
  • UPC 10653160344681
  • UPC 10653160330226
  • UPC 10193489191394
  • UPC 10193489784213
  • UPC 10888277732698
  • UPC 10653160264927
  • UPC 10653160355847
  • UPC 10193489193701
  • UPC 10653160259916
  • UPC 10889942742233
  • UPC 10193489193787
  • UPC 10193489196818
  • UPC 10193489111248
  • UPC 10653160308300
  • UPC 10653160320517
  • UPC 10653160356592
  • UPC 10653160328988
  • UPC 10653160314431
  • UPC 10653160269946
  • UPC 10653160279792
  • UPC 10193489396058
  • UPC 10653160261544
  • UPC 10653160327011
  • UPC 10889942492206
  • UPC 10889942446933
  • UPC 10653160321293
  • UPC 065316032558
  • UPC 10653160322139
  • UPC 10888277734036
  • UPC 10888277733121
  • UPC 10888277734173
  • UPC 10193489191554
  • UPC 10193489112412
  • UPC 00860000300636
  • UPC 10193489193299
  • UPC 065316006110
  • UPC 10193489782011
  • UPC 10889942453054
  • UPC 10888277295674
  • UPC 10193489197396
  • UPC 10193489194937
  • UPC 10889942784059
  • UPC 10653160329602
  • UPC 10653160287049
  • UPC 10653160322856
  • UPC 10653160328254
  • UPC 10653160338536
  • UPC 10889942780198
  • UPC 10653160314370
  • UPC 10653160307037
  • UPC 10193489193909
  • UPC 10193489111033
  • UPC 10653160357872
  • UPC 10653160284451
  • UPC 10653160291268
  • UPC 10889942708505
  • UPC 10653160353553
  • UPC 10653160358534
  • UPC 10653160314592
Source:

As FDA’s description and codes give them; the UPCs written as digits only.

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 the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

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.

Source:

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on May 15, 2023.
  • FDA classified it on Aug 3, 2023.
  • FDA’s Enforcement Report published it on Aug 9, 2023.
Source:

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.
Source:

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 5,839 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.
Source:

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

  • 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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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