Hearth Record

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

Medical device recall Z-2305-2023. 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. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; e. AFCH CVC INSERTION, Model Number: DYNJ67534; f. ANGIOGRAM-DECH-LF, Model Number: DYNJ81725; g. ART LINE KIT ICH OR, Model Number: ART900; h. ARTERIAL LINE PACK, Model Number: DYNJ49235D; i. ARTERIOGRAM PACK, Model Number: DYNJ53095A, DYNJ55169G; j. AV FISTULA, Model Number: DYNJ64143A, DYNJ905219A, DYNJ906341C, DYNJ906945; k. AV FISTULA PACK, Model Number: DYNJ52093I, DYNJ62733, DYNJ66916, DYNJ67178; l. AV FISTULA PACK-LF, Model Number: DYNJ48428C, DYNJ64499A, DYNJ69167; m. AV SHUNT PACK-LF, Model Number: DYNJ0781844W; n. BARIATRIC KIT, Model Number: DYNJ901145F; o. BASIC VEIN PACK, Model Number: DYNJ69426; p. BCH VEIN ABLATION, Model Number: DYNJ69796; q. CATH LAB-VEIN PROCEDURES, Model Number: DYNJ60329A; r. CENTRAL LINE BUNDLE PACK-LF, Model Number: DYNJ22338K; s. CENTRAL LINE INSERTION KIT, Model Number: DYNJ52894A; t. CENTRAL LINE INSERTION PACK, Model Number: CVI4805; u. CENTRAL LINE KIT, Model Number: DYNDC2582A; v. CENTRAL LINE KIT UTMB, Model Number: DYNDC3061; w. CENTRAL LINE PACK, Model Number: DYNJ30087C, DYNJ48096B; x. CENTRAL LINE PACK-LF, Model Number: DYNJ0220136Q; y. CENTRAL LINE PLACEMENT PACK-LF, Model Number: DYNJ32358G; z. CENTRAL LINE PROCEDURE KIT, Model Number: DT22260; aa. CENTRAL LINE TRAY, Model Number: CVI4705; bb. CENTRAL VENOUS ACCESS PACK-LF, Model Number: DYNJ0214541O; cc. CVC/PICC INSERTION PACK EH-LF, Model Number: DYNJ40204A, DYNJ40204B; dd. CVL PACK, Model Number: DYNJ00281O; ee. CVR ENDOVENOUS PACK, Model Number: DYNJ80643; ff. DBD-AV FISTULA, Model Number: DYNJ904398D; gg. DBD-CENTRAL LINE TRAY, Model Number: DYNJ42902C; hh. DBD-LEE VEIN PACK, Model Number: DYNJ54906C; ii. DBD-PICC LINE PACK-LF, Model Number: DYNJ0373077O; jj. DBD-VARICOSE VEIN PACK, Model Number: DYNJ82884, DYNJ82885; kk. DBD-VASCULAR PACK-LF, Model Number: DYNJ56968; ll. DBD-VASCULAR VEIN PACK, Model Number: DYNJ69769; mm. DBD-VEIN PACK, Model Number: DYNJ82033; nn. DBD-VENCLOSE PROCEDURE PACK, Model Number: DYNJ80123; oo. DBD-VENOUS ACCESS PORT INSERTION, Model Number: DYNJ902602I; pp. DBD-VENOUS PACK, Model Number: DYNJ44243C, DYNJ80692; qq. DECLOT ACCESS, Model Number: DYNJ907279A, DYNJ907279B; rr. DEXMED ACCESS PACK, Model Number: DYNJ83148; ss. ENDOVENOUS ABLATION PACK, Model Number: DYNJ53435D; tt. ENS PICC LINE-HEJ-LF, Model Number: DYNJ67606; uu. ENSEMBLE POWER PICC-HEJ-LF, Model Number: DYNJ65827; vv. ER CENTRAL LINE KIT, Model Number: P155508D; ww. FISTULA SAVANNAH PACK, Model Number: DYNJ69943; xx. FISTULAGRAM PACK-LF, Model Number: DYNJ63213; yy. FNA TRAY, Model Number: DYNDH1123B; zz. GENERAL AV FISTULA, Model Number: DYNJ906011B; aaa. GROTH LASER VEIN CDS, Model Number: CDS984193Q; bbb. I.R. PICC PACK, Model Number: DYNDA2759; ccc. IR CENTRAL VENOUS ACCESS, Model Number: DYNJ43267G; ddd. IR PICC TRAY, Model Number: DYNDH1223; eee. JVL-PACK PICC, Model Number: DYNJ66062; fff. KIT MAJOR VASCULAR, Model Number: DYNJ907262A; ggg. KIT VEIN ABLATION, Model Number: DYNJ907381; hhh. LASER VEIN EC PACK, Model Number: DYNJ82951; iii. MAX BARRIER ART LINE KIT, Model Number: ART950; jjj. MHC AV FISTULA, Model Number: DYNJ903705G; kkk. MID HUDSON PICC LINE PACK, Model Number: DYNJ53618A; lll. MIDLINE INSERTION KIT, Model Number: DYNJ45178; mmm. MSB BEDSIDE TRAY, Model Number: DYNJ54670; nnn. MV-IR-PICC PACK-LF, Model Number: DYNJ41554C; ooo. NENTRAL LINE TRAY, Model Number: DYNJ42902D; ppp. NEONATAL PICC LINE TRAY, Model Number: DYNDC2120B; qqq. OPEN VASCULA

146,157 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: DYNJ65711, UPC Number: 019348928509. b. Model Number: DYNJ64141A, UPC Number: 019532727957. c.…

Every code shown here, 1,994 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: DYNJ65711, UPC Number: 019348928509. b. Model Number: DYNJ64141A, UPC Number: 019532727957. c. Model Number: DYNJ40682B, UPC Number: 088994226721. d. Model Number: DYNDA2482, UPC Number: 019348935160. e. Model Number: DYNJ67534, UPC Number: 019348940932. f. Model Number: DYNJ81725, UPC Number: 019532713675. g. Model Number: ART900, UPC Number: 065316034254. h. Model Number: DYNJ49235D, UPC Number: 019348989433. i. Model Number: DYNJ53095A, UPC Number: 019532714872; Model Number: DYNJ55169G, UPC Number: 019348996756. j. Model Number: DYNJ64143A, UPC Number: 019348928481; Model Number: DYNJ905219A, UPC Number: 019348928721; Model Number: DYNJ906341C, UPC Number: 019348981630; Model Number: DYNJ906945, UPC Number: 019348929927. k. Model Number: DYNJ52093I, UPC Number: 019348933747; Model Number: DYNJ62733, UPC Number: 019348968502; Model Number: DYNJ66916, UPC Number: 019348938765; Model Number: DYNJ67178, UPC Number: 019348941674. l. Model Number: DYNJ48428C, UPC Number: 019348970247; Model Number: DYNJ64499A, UPC Number: 019348986330; Model Number: DYNJ69167, UPC Number: 019348989918. m. Model Number: DYNJ0781844W, UPC Number: 019348922653. n. Model Number: DYNJ901145F, UPC Number: 019348932609. o. Model Number: DYNJ69426, UPC Number: 019348993939. p. Model Number: DYNJ69796, UPC Number: 019348997935. q. Model Number: DYNJ60329A, UPC Number: 019348997222. r. Model Number: DYNJ22338K, UPC Number: 019348936830. s. Model Number: DYNJ52894A, UPC Number: 088994243754. t. Model Number: CVI4805, UPC Number: 019532706871. u. Model Number: DYNDC2582A, UPC Number: 019348934939. v. Model Number: DYNDC3061, UPC Number: 019348949581. w. Model Number: DYNJ30087C, UPC Number: 088994275414; Model Number: DYNJ48096B, UPC Number: 088827793931. x. Model Number: DYNJ0220136Q, UPC Number: 019348982348. y. Model Number: DYNJ32358G, UPC Number:…

FDA’s list runs to 8,917 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 019348928509
  • UPC 019532727957
  • UPC 088994226721
  • UPC 019348935160
  • UPC 019348940932
  • UPC 019532713675
  • UPC 065316034254
  • UPC 019348989433
  • UPC 019532714872
  • UPC 019348996756
  • UPC 019348928481
  • UPC 019348928721
  • UPC 019348981630
  • UPC 019348929927
  • UPC 019348933747
  • UPC 019348968502
  • UPC 019348938765
  • UPC 019348941674
  • UPC 019348970247
  • UPC 019348986330
  • UPC 019348989918
  • UPC 019348922653
  • UPC 019348932609
  • UPC 019348993939
  • UPC 019348997935
  • UPC 019348997222
  • UPC 019348936830
  • UPC 088994243754
  • UPC 019532706871
  • UPC 019348934939
  • UPC 019348949581
  • UPC 088994275414
  • UPC 088827793931
  • UPC 019348982348
  • UPC 088994252647
  • UPC 065316032919
  • UPC 019348983237
  • UPC 019532708888
  • UPC 088994240964
  • UPC 019532717845
  • UPC 019348996296
  • UPC 019532705579
  • UPC 019348970132
  • UPC 019532708468
  • UPC 019532718876
  • UPC 088994236495
  • UPC 019532721599
  • UPC 019532721600
  • UPC 088994269923
  • UPC 019348997779
  • UPC 019532716297
  • UPC 019532700918
  • UPC 019348989256
  • UPC 019348970140
  • UPC 019532706554
  • UPC 019348990771
  • UPC 019532711639
  • UPC 019532723551
  • UPC 019532719644
  • UPC 019348942167
  • UPC 019348929849
  • UPC 019348989906
  • UPC 019348999844
  • UPC 019348972821
  • UPC 019348946555
  • UPC 019348941123
  • UPC 019532725508
  • UPC 019348948819
  • UPC 019532728880
  • UPC 10889942567539
  • UPC 019348931921
  • UPC 019348990913
  • UPC 019348990077
  • UPC 019532721897
  • UPC 065316033022
  • UPC 019348934550
  • UPC 088994249249
  • UPC 088827709574
  • UPC 088994249957
  • UPC 088994281132
  • UPC 019532717110
  • UPC 019348936335
  • UPC 019348990935
  • UPC 019532712377
  • UPC 019532713232
  • UPC 019532725343
  • UPC 065316025639
  • UPC 065316099195
  • UPC 088994202437
  • UPC 019348989850
  • UPC 019348994102
  • UPC 065316026994
  • UPC 019348939605
  • UPC 019532703833
  • UPC 019348958546
  • UPC 088827702610
  • UPC 019532717644
  • UPC 019348993088
  • UPC 088994248122
  • UPC 088994272280
  • UPC 088994272282
  • UPC 019348927672
  • UPC 019532705652
  • UPC 019348980028
  • UPC 019348956435
  • UPC 019532722477
  • UPC 088438933586
  • UPC 019348921520
  • UPC 019348938257
  • UPC 088994249268
  • UPC 019348961600
  • UPC 088994253218
  • UPC 019348990860
  • UPC 019348996757
  • UPC 019532713535
  • UPC 019348938136
  • UPC 019348930065
  • UPC 019532706927
  • UPC 019532724321
  • UPC 019348999404
  • UPC 019532709488
  • UPC 019532700967
  • UPC 019348945247
  • UPC 019532730102
  • UPC 019348945284
  • UPC 019348926312
  • UPC 019532725067
  • UPC 019532735530
  • UPC 088994237552
  • UPC 088994225370
  • UPC 019348948445
  • UPC 019348992170
  • UPC 019348930326
  • UPC 019348988361
  • UPC 019348997524
  • UPC 088994255095
  • UPC 088438906430
  • UPC 019348926164
  • UPC 088827789487
  • UPC 019348972089
  • UPC 088994249220
  • UPC 088438942826
  • UPC 088438990917
  • UPC 019532722158
  • UPC 019348976918
  • UPC 019532713677
  • UPC 019532710571
  • UPC 088994249468
  • UPC 088994274727
  • UPC 019348996758
  • UPC 019348928982
  • UPC 019532727671
  • UPC 019532700387
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 8,917 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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