Hearth Record

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

Medical device recall Z-2297-2023. 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. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A; b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A; c. 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC2205A; d. 16CM 7F CVC INSERTION TRAY, Model Number: ECVC8095; e. 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number: ECVC5010A; f. 16CM CVC INSERTION KIT, Model Number: ECVC6800A; g. 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555; h. 16CM TRIPLE LUMEN CVC INSERT BUNDLE, Model Number: ECVC4125; i. 20CM 3L 7FR CVC INSERTION BUNDLE, Model Number: ECVC5135B; j. 20CM 3L CVC INSERTION TRAY, Model Number: ECVC7325; k. 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B; l. 20CM 7F CVC INSERTION TRAY, Model Number: ECVC4335; m. 20CM CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC7160; n. 20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2560; o. 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505; p. 2L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC7075; q. 2L 8.5FR 16CM CVC INSERTION KIT, Model Number: ECVC8055; r. 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165; s. 3L 7FR 16CM CVC INSERTION BUNDLE, Model Numbers: ECVC4635A, ECVC7040A, ECVC7430, ECVC7475, ECVC7605, ECVC7675, ECVC8130, STCVC2055US; t. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600; u. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC4640A, ECVC6490A, ECVC6845, ECVC7470; v. 3L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC6170; w. 7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC3545; x. 7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC2440B; y. 7F 20CM 3L CVC VANTEX BUNDLE, Model Number: ECVC7350; z. 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480; aa. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC3475; bb. 7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number: ECVC2770; cc. 7FR 16CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC6370; dd. 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC7910; ee. 7FR 3L 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC7235, ECVC7905; ff. 7FR TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC2795; gg. 7FR,20CM,3L ANTIMICROBIAL CVC BUNDLE, Model Number: ECVC705; hh. 8.5F 16CM 2L CVC VANTEX BUNDLE, Model Number: ECVC7355; ii. 9F AVA HF RESUSCIT CVC BNDL, Model Number: ECVC6640; jj. ABLATION EP PACK, Model Number: DYNJ43851B; kk. ABLATION PACK, Model Number: DYNJ40629C; ll. ADULT CARDIAC CATH PACK, Model Numbers: DYNJ23455K, DYNJ23455L, DYNJ23455M, DYNJ23455N; mm. ANGIO, Model Numbers: DYNJ902507C, DYNJ905151B; nn. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609O, DYNJ43609P, DYNJ43609R, DYNJ43609S; oo. ANGIO CATH LAB PACK-LF, Model Numbers: DYNJ0313233V, DYNJ0313233W, DYNJ0313233X; pp. ANGIO CATH PACK, Model Number: DYNJ52000B; qq. ANGIO DRAPE PACK, Model Numbers: DYNJ44320G, DYNJ44320I, DYNJ44320J; rr. ANGIO DRAPE PACK (ADLUG)642-LF, Model Numbers: DYNJ47665D, DYNJ47665F; ss. ANGIO HOLLAND PACK-LF, Model Numbers: DYNJ0037936C, DYNJ0037936D; tt. ANGIO PACK, Model Numbers: DYNJ42903C, DYNJ42903D, DYNJ43661C, DYNJ44642B, DYNJ58111D, DYNJ58111F, DYNJ69200, DYNJ69951; uu. ANGIO PACK-LF, Model Number: DYNJ0407399P; vv. ANGIO SAVANNAH PACK, Model Number: DYNJ69944; ww. ANGIO TRAY, Model Number: DYNJ23438M, DYNJ52121A, DYNJ69421, DYNJ69792, DYNJ82999, DYNJ82999A; xx. ANGIO/PICC PACK, Model Number: DYNJ36049A; yy. ANGIOGRAM, Model Number: DYNJ0149444N; zz. ANGIOGRAPHIC TRAY, Model Number: DYNJ67320A; aaa. ANGIOGRAPHY DRAPE PACK, Model Numbers: 00-400305R, DYNJ49621C, DYNJ63060B, DYNJ63684G, DYNJ68065B, DYNJ63684G; bbb. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293F, DYNJ45059B, DYNJ55252C, DYNJ65190D, DYNJ65190F, DYNJ66476A, DYNJ67144A; ccc. ANGIOGRAPHY PACK-LF, Model Numbers: DYNJ0290716M, DYNJ0854485V; ddd. ANGIOPLASTY PACK, Model Number: DYNJ44700J; eee

97,677 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: DYNJ908249A, UPC Number: 019532724050. b. Model Number: ECVC7410A, UPC Number: 10653160353645. c.…

Every code shown here, 1,992 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: DYNJ908249A, UPC Number: 019532724050. b. Model Number: ECVC7410A, UPC Number: 10653160353645. c. Model Number: ECVC2205A, UPC Number: 10653160357148. d. Model Number: ECVC8095, UPC Number: 10653160357759. e. Model Number: ECVC5010A, UPC Number: 10653160335290. f. Model Number: ECVC6800A, UPC Number: 10653160355694. g. Model Number: ECVC2555, UPC Number: 10653160336570. h. Model Number: ECVC4125, UPC Number: 10653160339502. i. Model Number: ECVC5135B, UPC Number: 10653160353652. j. Model Number: ECVC7325, UPC Number: 10653160345589. k. Model Number: ECVC1970B, UPC Number: 10653160357155. l. Model Number: ECVC4335, UPC Number: 10653160357285. m. Model Number: ECVC7160, UPC Number: 10653160335306. n. Model Number: ECVC2560, UPC Number: 10653160334286. o. Model Number: ECVC3505, UPC Number: 10653160334767. p. Model Number: ECVC7075, UPC Number: 10653160335122. q. Model Number: ECVC8055, UPC Number: 10653160355656. r. Model Number: ECVC8165, UPC Number: 10653160358749. s. Model Number: ECVC4635A, UPC Number: 10653160352112; Model Number: ECVC7040A, UPC Number: 10653160344414; Model Number: ECVC7430, UPC Number: 10653160346524; Model Number: ECVC7475, UPC Number: 10653160347569; Model Number: ECVC7605, UPC Number: 10653160347743; Model Number: ECVC7675, UPC Number: 10653160348122; Model Number: ECVC8005, UPC Number: 10653160355137; Model Number: ECVC8130, UPC Number: 10653160358343; Model Number: STCVC2055US, UPC Number: 10653160355564. t. Model Number: ECVC7600, UPC Number: 10653160347736. u. Model Number: ECVC4640A, UPC Number: 10653160352105; Model Number: ECVC6490A, UPC Number: 10653160344360; Model Number: ECVC6845, UPC Number: 10653160339366; Model Number: ECVC7470, UPC Number: 10653160347583. v. Model Number: ECVC6170, UPC Number: 10653160333395. w. Model Number: ECVC3545, UPC Number: 10653160334774. x. Model Number:…

FDA’s list runs to 10,098 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 019532724050
  • UPC 10653160353645
  • UPC 10653160357148
  • UPC 10653160357759
  • UPC 10653160335290
  • UPC 10653160355694
  • UPC 10653160336570
  • UPC 10653160339502
  • UPC 10653160353652
  • UPC 10653160345589
  • UPC 10653160357155
  • UPC 10653160357285
  • UPC 10653160335306
  • UPC 10653160334286
  • UPC 10653160334767
  • UPC 10653160335122
  • UPC 10653160355656
  • UPC 10653160358749
  • UPC 10653160352112
  • UPC 10653160344414
  • UPC 10653160346524
  • UPC 10653160347569
  • UPC 10653160347743
  • UPC 10653160348122
  • UPC 10653160355137
  • UPC 10653160358343
  • UPC 10653160355564
  • UPC 10653160347736
  • UPC 10653160352105
  • UPC 10653160344360
  • UPC 10653160339366
  • UPC 10653160347583
  • UPC 10653160333395
  • UPC 10653160334774
  • UPC 10653160358930
  • UPC 10653160346265
  • UPC 10653160339458
  • UPC 10653160334736
  • UPC 10653160332671
  • UPC 10653160333425
  • UPC 10653160357254
  • UPC 10653160341703
  • UPC 10653160356912
  • UPC 10653160334200
  • UPC 10653160331889
  • UPC 10653160346272
  • UPC 10653160333494
  • UPC 019532720032
  • UPC 019348999731
  • UPC 019348956435
  • UPC 019532723775
  • UPC 019532713788
  • UPC 019532721996
  • UPC 019348946871
  • UPC 019348991453
  • UPC 019532722878
  • UPC 019532732298
  • UPC 019532725098
  • UPC 019348938498
  • UPC 019348996630
  • UPC 019532707035
  • UPC 019532713235
  • UPC 019348995282
  • UPC 019532735521
  • UPC 019532712953
  • UPC 019532707966
  • UPC 019532717111
  • UPC 019532710435
  • UPC 019532701142
  • UPC 019348993292
  • UPC 019532722351
  • UPC 019348990681
  • UPC 019532700030
  • UPC 019532733686
  • UPC 019348999845
  • UPC 019348997060
  • UPC 019532726009
  • UPC 019348993759
  • UPC 019348997928
  • UPC 019532722310
  • UPC 019532731027
  • UPC 019532714720
  • UPC 019348996671
  • UPC 019348993757
  • UPC 019348994428
  • UPC 019532700858
  • UPC 019348991282
  • UPC 019532703722
  • UPC 019532701333
  • UPC 019532726518
  • UPC 088994213563
  • UPC 019532726791
  • UPC 019532706664
  • UPC 019532709265
  • UPC 019532705189
  • UPC 019532717902
  • UPC 019532708886
  • UPC 019532709688
  • UPC 019532727741
  • UPC 019348995291
  • UPC 019348996101
  • UPC 019532717289
  • UPC 019532728879
  • UPC 088994232247
  • UPC 088994237177
  • UPC 019348972168
  • UPC 019348984849
  • UPC 019348997067
  • UPC 10653160355427
  • UPC 10653160311829
  • UPC 10653160332770
  • UPC 10653160339977
  • UPC 10653160351535
  • UPC 10653160341543
  • UPC 10653160341512
  • UPC 10653160341505
  • UPC 10653160334873
  • UPC 10653160334279
  • UPC 10653160334071
  • UPC 10653160346166
  • UPC 019348926312
  • UPC 088994275695
  • UPC 019348947402
  • UPC 019348991486
  • UPC 019532704680
  • UPC 019532713108
  • UPC 019532718392
  • UPC 019532718420
  • UPC 019532728860
  • UPC 019532709484
  • UPC 019348998843
  • UPC 019532708236
  • UPC 10653160338178
  • UPC 019348994382
  • UPC 019348932098
  • UPC 088994271392
  • UPC 088994271393
  • UPC 088994263978
  • UPC 019348983759
  • UPC 019532726478
  • UPC 019348999048
  • UPC 019532713721
  • UPC 019348938623
  • UPC 019348952796
  • UPC 019348939599
  • UPC 019348945396
  • UPC 019348951627
  • UPC 019532701780
  • UPC 088994297098
  • UPC 019348924171
  • UPC 019348987983
  • UPC 019532703407
  • UPC 019532704548
  • UPC 019532712721
  • UPC 019532724200
  • UPC 019348991777
  • UPC 019532723083
  • UPC 019532723151
  • UPC 10653160336693
  • UPC 10653160332855
  • UPC 10653160336105
  • UPC 10653160334224
  • UPC 10653160334217
  • UPC 10653160331964
  • UPC 10653160334330
  • UPC 10653160332473
  • UPC 10653160334606
  • UPC 10653160334507
  • UPC 019532710379
  • UPC 10653160345596
  • UPC 019532711141
  • UPC 019532726199
  • UPC 10195327188818
  • UPC 10195327310608
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 10,098 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.

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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.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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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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