Hearth Record

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

Medical device recall Z-2299-2023. 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. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Model Number: STCVC20US; d. MULTIMED 7F 2L 16CM STOCK + BUNDLE US, Model Number: STCVC21US; e. MULTIMED 7F 3L 16CM CVC BUNDLE, Model Number: ECVC6585A; f. MULTIMED 7F 3L 20CM PI, Model Number: ECVC7235A; g. MULTIMED 7FR 16CM CVC STK + BUNDLE-US, Model Number: STCVC03US; h. MULTIMED 7FR 3L 16CM CVC BUNDLE, Model Number: ECVC6655A; i. MULTIMED 7FR 3L 20CM CVC BUNDLE-US, Model Number: ECVC7935; j. MULTIMED 7FR 3L 20CM CVC STK + BUNDLE-US, Model Number: STCVC04US; k. MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: ECVC7670; l. MULTIMED 8.5F 20CM QUAD CVC BUNDLE, Model Number: ECVC7090; m. MULTIMED 8.5FR 16CM QUAD CVC BUNDLE, Model Number: ECVC6930; n. MULTIMED 8.5FR 2L 16CM CVC STK+BUNDLE-US, Model Number: STCVC13US; o. NEURO CATH PACK (NCLUA)227-LF, Model Number: DYNJ47646D, DYNJ47646F, DYNJ47646G, DYNJ47646I; p. O.R. DOUBLE LUMEN INSERTION TRAY, Model Number: ECVC8010; q. OLEAN GENERAL CVC BUNDLE, Model Number: ECVC4615; r. OR ANGIO PACK, Model Number: DYNJ59184B; s. OR ANGIOGRAM, Model Number: DYNJ909267; t. OR ANGIOGRAPHY DRAPE, Model Number: DYNJ906297D; u. OR ANGIOGRAPHY PACK, Model Numbers: DYNJ67245A, DYNJ67245B; v. OR PERCUTANEOUS CATH PACK, Model Number: DYNJ63372A, DYNJ63372B, DYNJ63372C, DYNJ63372D; w. OR VANTEX 7FR 3L 16CM CVC, Model Number: ECVC6665; x. OR VASCULAR ANGIO PACK, Model Number: DYNJ69763, DYNJ69763A; y. PACK CARDIAC CATH, Model Number: DYNJ65481; z. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112B; aa. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755G, DYNJ54755I; bb. PEDIATRIC CATH PACK-LF, Model Number: DYNJ0843244K; cc. PERCUTANEOUS ANGIO PACK-LF, Model Number: DYNJ57645C; dd. PERCUTANEOUS PACK, Model Number: DYNJ46035C, DYNJ46035D; ee. PERMA CATH PACK, Model Number: DYNJ62007A; ff. PI CVC BUNDLE, VANTEX 3L, 16CM, Model Number: ECVC3665; gg. PI CVC BUNDLE, VANTEX 3L, 20CM, Model Number: ECVC6190; hh. PI VANTEX 7FR 16CM 3L CVC BUNDLE-MAXPLUS, Model Number: ECVC4380; ii. PI VANTEX 7FR 16CM 3L CVC-MicroClave, Model Number: ECVC5655; jj. PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number: ECVC5650; kk. PI VANTEX 8.5FR 16CM 4L CVC-MicroClave, Model Number: ECVC5660; ll. PI VANTEX 8.5FR 20CM 4L CVC-MicroClave, Model Number: ECVC5685; mm. PICC LINE PACK-LF, Model Number: DYNJ0275614F; nn. PK, RADIOLOGY, Model Number: DYNJ43894B; oo. PORT A CATH PACK, Model Number: DYNJ59307F; pp. PORT PACK, Model Number: DYNJ58162; qq. PORTACATH PACK, Model Number: DYNJ51240A; rr. QUAD LUMEN CVC BUNDLE 8.5F, 16CM, Model Number: ECVC3700; ss. QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number: ECVC4995; tt. QUAD LUMEN CVC INSERTION BUNDLE, Model Numbers: ECVC5025, ECVC4135; uu. QUAD LUMEN KIT, Model Number: ECVC5820; vv. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ65913; ww. RADIOLOGY PACK, Model Numbers: DYNJ41190, DYNJ43894A, DYNJ44087A, DYNJ44524F, DYNJ52806C; xx. RADIOLOGY PACK 108402-LF, Model Number: DYNJVB1000; yy. RR-ADULT ECMO PACK, Model Number: DYNJ69742, DYNJ69742B; zz. SHEATH INTRODUCER BUNDLE, Model Number: ECVC2930, ECVC5835; aaa. SK-ANGIO TRAY-LF, Model Number: DYNJ82030; bbb. SK-INTERVENTIONAL TRAY-LF, Model Number: DYNJ82041; ccc. SPECIAL PROCEDURE CATH LAB PK, Model Number: DYNJ68729; ddd. SPECIAL PROCEDURE PACK, Model Number: DYNJ38314G; eee. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535AA, DYNJ0416535W, DYNJ0458661C; fff. SPECIAL PROCEDURE PK-LF, Model Number: DYNJ0604508R; ggg. SPECIAL PROCEDURES, Model Number: DYNJ23288C; hhh. STANDARD ANGIO TRAY MV, Model Number: DYNJ67136A; iii. STD, AVA ,3XI ,3L 8.5F KIC, Model Number: ECVC7465A; jjj. STD, AVA, 3L, 9F, HF, KIC, Model Number: ECVC810

104,755 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: ECVC475, UPC Number: 10653160333081. b. Model Number: ECVC3900, UPC Number: 10653160334828. c.…

Every code shown here, 1,991 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: ECVC475, UPC Number: 10653160333081. b. Model Number: ECVC3900, UPC Number: 10653160334828. c. Model Number: STCVC20US, UPC Number: 10653160339076. d. Model Number: STCVC21US, UPC Number: 10653160339045. e. Model Number: ECVC6585A, UPC Number: 10653160338826. f. Model Number: ECVC7235A, UPC Number: 10653160354550. g. Model Number: STCVC03US, UPC Number: 10653160339212. h. Model Number: ECVC6655A, UPC Number:10653160339267. i. Model Number: ECVC7935, UPC Number: 10653160353669. j. Model Number: STCVC04US, UPC Number: 10653160339199. k. Model Number: ECVC7670, UPC Number:10653160348054. l. Model Number: ECVC7090, UPC Number: 10653160339243. m. Model Number: ECVC6930, UPC Number:10653160339250. n. Model Number: STCVC13US, UPC Number: 10653160339137. o. Model Number: DYNJ47646D, UPC Number: 019348995047; Model Number: DYNJ47646F, UPC Number: 019532715551; Model Number: DYNJ47646G, UPC Number: 019532717502; Model Number: DYNJ47646I, UPC Number: 019532735712. p. Model Number: ECVC8010, UPC Number: 10653160356356. q. Model Number: ECVC4615, UPC Number: 10653160336075. r. Model Number: DYNJ59184B, UPC Number: 019348994910. s. Model Number: DYNJ909267, UPC Number: 019532731461. t. Model Number: DYNJ906297D, UPC Number: 019532714128. u. Model Number: DYNJ67245A, UPC Number: 019532702425; Model Number: DYNJ67245B, UPC Number: 019532729222. v. Model Number: DYNJ63372A, UPC Number: 019348929205; Model Number: DYNJ63372B, UPC Number: 019348947044; Model Number: DYNJ63372C, UPC Number: 019532708614; Model Number: DYNJ63372D, UPC Number: 019532727047. w. Model Number: ECVC6665, UPC Number: 10653160337843. x. Model Number: DYNJ69763, UPC Number: 019348997737; Model Number: DYNJ69763A, UPC Number: 019532733001. y. Model Number: DYNJ65481, UPC Number: 019348928046. z. Model Number: DYNJ60112B, UPC Number: 019532711884. aa. Model Number:…

FDA’s list runs to 11,557 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 10653160333081
  • UPC 10653160334828
  • UPC 10653160339076
  • UPC 10653160339045
  • UPC 10653160338826
  • UPC 10653160354550
  • UPC 10653160339212
  • UPC 10653160339267
  • UPC 10653160353669
  • UPC 10653160339199
  • UPC 10653160348054
  • UPC 10653160339243
  • UPC 10653160339250
  • UPC 10653160339137
  • UPC 019348995047
  • UPC 019532715551
  • UPC 019532717502
  • UPC 019532735712
  • UPC 10653160356356
  • UPC 10653160336075
  • UPC 019348994910
  • UPC 019532731461
  • UPC 019532714128
  • UPC 019532702425
  • UPC 019532729222
  • UPC 019348929205
  • UPC 019348947044
  • UPC 019532708614
  • UPC 019532727047
  • UPC 10653160337843
  • UPC 019348997737
  • UPC 019532733001
  • UPC 019348928046
  • UPC 019532711884
  • UPC 019348998776
  • UPC 019532702126
  • UPC 019532728859
  • UPC 019532728741
  • UPC 019348934095
  • UPC 019348949364
  • UPC 019348987890
  • UPC 10653160336044
  • UPC 10653160337751
  • UPC 10653160338147
  • UPC 10653160337621
  • UPC 10653160336457
  • UPC 10653160337638
  • UPC 10653160337652
  • UPC 088994217434
  • UPC 019348981048
  • UPC 019532705885
  • UPC 088994282933
  • UPC 088994249352
  • UPC 10653160332886
  • UPC 10653160335283
  • UPC 10653160333142
  • UPC 10653160335900
  • UPC 10653160338123
  • UPC 019348930317
  • UPC 088438989908
  • UPC 088994213269
  • UPC 088994256180
  • UPC 019348946748
  • UPC 019348929290
  • UPC 019348980099
  • UPC 019348997490
  • UPC 019532713688
  • UPC 10653160335368
  • UPC 10653160333364
  • UPC 019532716237
  • UPC 019532716221
  • UPC 019348983654
  • UPC 019348960334
  • UPC 019532735459
  • UPC 019348956435
  • UPC 088994255094
  • UPC 019348982844
  • UPC 019348995414
  • UPC 019348993567
  • UPC 10653160350088
  • UPC 10653160357841
  • UPC 019532713118
  • UPC 019532708511
  • UPC 019348994014
  • UPC 019532724865
  • UPC 10653160345060
  • UPC 10653160352792
  • UPC 10653160338611
  • UPC 10653160334132
  • UPC 10653160338116
  • UPC 10653160338956
  • UPC 10653160338635
  • UPC 10653160336419
  • UPC 10653160331735
  • UPC 10653160336150
  • UPC 10653160333548
  • UPC 10653160343165
  • UPC 10653160347699
  • UPC 10653160336785
  • UPC 10653160345701
  • UPC 10653160344933
  • UPC 10653160357742
  • UPC 10653160338413
  • UPC 10653160334453
  • UPC 10653160338383
  • UPC 10653160335849
  • UPC 10653160339397
  • UPC 10653160334798
  • UPC 10653160333982
  • UPC 10653160340591
  • UPC 10653160332794
  • UPC 10653160336006
  • UPC 10653160336013
  • UPC 10653160333111
  • UPC 10653160334903
  • UPC 10653160358251
  • UPC 10653160334934
  • UPC 10653160336198
  • UPC 10653160336372
  • UPC 10653160332183
  • UPC 10653160359036
  • UPC 10653160334569
  • UPC 10653160358794
  • UPC 10653160332268
  • UPC 10653160336402
  • UPC 019532726533
  • UPC 019348964108
  • UPC 019348958812
  • UPC 10653160254935
  • UPC 10653160333524
  • UPC 10653160337867
  • UPC 10653160337164
  • UPC 10653160337850
  • UPC 10653160336617
  • UPC 10653160353980
  • UPC 10653160335115
  • UPC 10653160336761
  • UPC 10653160336778
  • UPC 10653160354802
  • UPC 10653160348009
  • UPC 10653160348153
  • UPC 10653160337492
  • UPC 10653160336600
  • UPC 10653160358558
  • UPC 10653160358404
  • UPC 10653160353355
  • UPC 10653160335276
  • UPC 10653160337485
  • UPC 10653160350279
  • UPC 10653160342700
  • UPC 10653160344292
  • UPC 10653160355366
  • UPC 10193489199956
  • UPC 10653160353881
  • UPC 10653160355601
  • UPC 10653160353966
  • UPC 10653160356295
  • UPC 10653160355328
  • UPC 10653160336815
  • UPC 10653160358589
  • UPC 10653160347132
  • UPC 10653160344650
  • UPC 10653160336839
  • UPC 10653160355748
  • UPC 10653160336327
  • UPC 10653160344698
  • UPC 10653160347705
  • UPC 10653160353867
  • UPC 10653160355458
  • UPC 10653160355595
  • UPC 10653160356905
  • UPC 10653160355434
  • UPC 10653160355700
  • UPC 10653160347682
  • UPC 10653160355342
  • UPC 10653160336846
  • UPC 10653160358565
  • UPC 10653160347750
  • UPC 10653160335894
  • UPC 10653160336624
  • UPC 10653160347804
  • UPC 10653160346210
  • UPC 10653160347392
  • UPC 10653160348375
  • UPC 10653160336495
  • UPC 10653160335092
  • UPC 10653160349365
  • UPC 10653160336631
  • UPC 10653160352853
  • UPC 10653160355359
  • UPC 10653160356899
  • UPC 10653160338314
  • UPC 10653160335795
  • UPC 10653160336525
  • UPC 10653160336488
  • UPC 10653160337690
  • UPC 10653160336716
  • UPC 10193489196399
  • UPC 10653160336723
  • UPC 10653160336679
  • UPC 10653160334835
  • UPC 10653160355038
  • UPC 019532706950
  • UPC 10653160345565
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 11,557 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.

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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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