Hearth Record

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

Medical device recall Z-2302-2023. 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. OPEN HEART CDS-LF, Model Number: CDS840451L; b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A; c. OPEN HEART PACK, Model Number: DYNJ43741B, DYNJ66216, DYNJ66216A, DYNJ66216B, DYNJ66216C; d. OPEN HEART PACK A B, Model Number: DYNJ53984G; e. OPEN HEART PACK A & B, Model Number: DYNJ0283397T, DYNJ0283397U, DYNJ53984F, DYNJ53984G; f. OPEN HEART PACK-LF, Model Number: DYNJ0371669N; g. OPEN HEART PACK-RF-LF, Model Number: DYNJ22232W; h. OPEN HEART PART 2, Model Number: DYNJ901075O, DYNJ901075P; i. OPEN HEART PROCEDURE, Model Number: DYNJ901821A; j. OPEN HEART TAVR CONVERSION PK, Model Number: DYNJ63153B; k. OPEN HEART TAVR PACK, Model Number: DYNJ63099F; l. OPEN VASCULAR UE, Model Number: DYNJ907858A; m. OPEN VASCULAR UE PACK, Model Number: DYNJ62451; n. OR ENDOVASCULAR, Model Number: DYNJ906019B, DYNJ906019C; o. OR INTERVENTIONAL PACK, Model Number: DYNJ81295; p. PACER SET UP PACK, Model Number: DYNJ63069A; q. PACK AV FISTULA, Model Number: DYNJ60115B; r. PACK MINOR VASCULAR, Model Number: NG340C; s. PACK VASCULAR BYPASS, Model Number: DYNJ905692D; t. PEDI EP PACK, Model Number: DYNJ54750G; u. PEDIATRIC CARDIO CATH PACK, Model Number: DYNJ35578G; v. PERCUTANEOUS VASCULAR CDS, Model Number: CDS840487I; w. PERIPHERAL CONTINUOUS NERVE BL, Model Number: PAIN1423A; x. PERIPHERAL VASCULAR, Model Number: DYNJ44562F, DYNJ901068D, DYNJ901068F, DYNJ901068I; y. PERIPHERAL VASCULAR GRAFT, Model Number: SYNJ910022A, SYNJ910022B, SYNJ910022C; z. PERIPHERAL VASCULAR PACK, Model Number: DYNJ82566; aa. PERMA CATH PACK, Model Number: DYNJ62007B; bb. PICC VASCULAR ACCESS PACK, Model Number: PICCNC0010; cc. PK OPEN HEART, Model Number: DYNJ45074C, DYNJ61645A; dd. PK, OPEN HEART, Model Number: DYNJ61645A; ee. PK, VASCULAR, Model Number: DYNJ54305; ff. PORT PACK, Model Number: DYNJ68990A; gg. PORT PICC TUNNEL PACK, Model Number: DYNJ65775A; hh. PQ2 VASCULAR PACK, Model Number: DYNJ68492; ii. PROCEDURE PACK, Model Number: DYNJ43922, DYNJ68968A, DYNJ81618; jj. PRX AV FISTULA PACK, Model Number: DYNJ66184; kk. PUH PERCUTANEOUS ECMO, Model Number: DYNJ907554A, DYNJ907554C; ll. PUMP PACK, Model Number: DYNJ64601B; mm. PURPLE PACK, Model Number: DYNJ62197A, DYNJ62197B; nn. PV CAROTID PACK, Model Number: DYNJ63341D; oo. PV PACK, Model Number: DYNJ46549K, DYNJ46549L; pp. RF OPEN HEART PACK (OHLUK)642, Model Number: DYNJ47660K; qq. RFA VEIN PACK-LF, Model Number: DYNJ61894A; rr. RFD-CAROTID, Model Number: DYNJ54287B; ss. RFD-ENDOVASCULAR OR PACK, Model Number: DYNJ54265A; tt. RFD-MAJOR VASCULAR, Model Number: DYNJ54285B; uu. RFD-MINOR VASCULAR, Model Number: DYNJ54286B; vv. RIGHT HEART PACK-LF, Model Number: DYNJ0565558U; ww. RIGHT HEART TRAY, Model Number: DYNJ40379D; xx. ROCKWAY VASCULAR PACK-LF, Model Number: DYNJ55757C; yy. RRMC CAROTID PACK-2, Model Number: DYNJ33544J, DYNJ33544K, DYNJ33544L; zz. SAC OPEN HEART DR. RUDERSDORF, Model Number: DYNJ908074B; aaa. SCA VEIN PACK, Model Number: DYNJ63817; bbb. SILVER CROSS OPEN HEART, Model Number: DYNJ906102D, DYNJ906102F; ccc. SMALL CARDIOVASCULAR PACK, Model Number: DYNJ83521; ddd. SMALL TRAY VASCULAR PACK, Model Number: DYNJ65418; eee. SPECIALS MINOR RADIOLOGY PACK, Model Number: DYNJ82314; fff. ST CHARLES PORT PACK, Model Number: DYNJ49833I; ggg. ST MARY’S STL OPEN HRT SUPPLY, Model Number: DYNJ20031C; hhh. STEWARD OR VASCULAR PACK G, Model Number: DYNJ80918; iii. STEWARD VASCULAR SAS, Model Number: DYNJ908563; jjj. STROKE KIT, Model Number: DYNJ80506; kkk. STROKE PACK, Model Number: DYNJ69009, DYNJ69009A; lll. SUMMIT SKIN AND VEIN PACK, Model Number: DYNJ54014B; mmm. SVMMC CAROTID PACK, Model Number: DYNJ43861F; nnn. SVMMC AV

43,149 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: CDS840451L, UPC Number: 019532715163. b. Model Number: DYNJ908179, UPC Number: 019348999908; Model…

Every code shown here, 1,997 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: CDS840451L, UPC Number: 019532715163. b. Model Number: DYNJ908179, UPC Number: 019348999908; Model Number: DYNJ908179A, UPC Number: 019532722257. c. Model Number: DYNJ43741B, UPC Number: 088994282107; Model Number: DYNJ66216, UPC Number: 019348932622; Model Number: DYNJ66216A, UPC Number: 019348991365; Model Number: DYNJ66216B, UPC Number: 019532703430; Model Number: DYNJ66216C, UPC Number: 019532734492. d. Model Number: DYNJ53984G, UPC Number: 019532728288. e. Model Number: DYNJ0283397T, UPC Number: 019348956435; Model Number: DYNJ0283397U, UPC Number: 019532708366; Model Number: DYNJ53984F, UPC Number: 019348946948; Model Number: DYNJ53984G, UPC Number: 019532728288. f. Model Number: DYNJ0371669N, UPC Number: 019348923039. g. Model Number: DYNJ22232W, UPC Number: 019532732560. h. Model Number: DYNJ901075O, UPC Number: 019532705268; Model Number: DYNJ901075P, UPC Number: 019532725355. i. Model Number: DYNJ901821A, UPC Number: 019532731932. j. Model Number: DYNJ63153B, UPC Number: 019348984168. k. Model Number: DYNJ63099F, UPC Number: 019532715003. l. Model Number: DYNJ907858A, UPC Number: 019532713135. m. Model Number: DYNJ62451, UPC Number: 019348965833. n. Model Number: DYNJ906019C, UPC Number: 019348941128. o. Model Number: DYNJ81295, UPC Number: 019532710670. p. Model Number: DYNJ63069A, UPC Number: 019348942361. q. Model Number: DYNJ60115B, UPC Number: 019532711880. r. Model Number: NG340C, UPC Number: 019532730520. s. Model Number: DYNJ905692D, UPC Number: 019532720229. t. Model Number: DYNJ54750G, UPC Number: 019532702135. u. Model Number: DYNJ35578G, UPC Number: 019348980860. v. Model Number: CDS840487I, UPC Number: 019348944534. w. Model Number: PAIN1423A, UPC Number: 019348920182. x. Model Number: DYNJ44562F, UPC Number: 019348973734; Model Number: DYNJ901068D, UPC Number: 019348921186; Model Number: DYNJ901068F,…

FDA’s list runs to 9,555 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 019532715163
  • UPC 019348999908
  • UPC 019532722257
  • UPC 088994282107
  • UPC 019348932622
  • UPC 019348991365
  • UPC 019532703430
  • UPC 019532734492
  • UPC 019532728288
  • UPC 019348956435
  • UPC 019532708366
  • UPC 019348946948
  • UPC 019348923039
  • UPC 019532732560
  • UPC 019532705268
  • UPC 019532725355
  • UPC 019532731932
  • UPC 019348984168
  • UPC 019532715003
  • UPC 019532713135
  • UPC 019348965833
  • UPC 019348941128
  • UPC 019532710670
  • UPC 019348942361
  • UPC 019532711880
  • UPC 019532730520
  • UPC 019532720229
  • UPC 019532702135
  • UPC 019348980860
  • UPC 019348944534
  • UPC 019348920182
  • UPC 019348973734
  • UPC 019348921186
  • UPC 019348994461
  • UPC 019532723251
  • UPC 019348937421
  • UPC 019532700726
  • UPC 019532735820
  • UPC 019532719802
  • UPC 019532716196
  • UPC 019532723117
  • UPC 019348922267
  • UPC 019348978134
  • UPC 088994247639
  • UPC 019348998136
  • UPC 019532714022
  • UPC 019348982724
  • UPC 088827707466
  • UPC 019532720684
  • UPC 019532712460
  • UPC 019348932118
  • UPC 019532702463
  • UPC 019532718383
  • UPC 019532728473
  • UPC 019348999409
  • UPC 019532716724
  • UPC 019532727362
  • UPC 019532700829
  • UPC 019532729066
  • UPC 019348987573
  • UPC 019348973096
  • UPC 019532716711
  • UPC 019532715233
  • UPC 019532714203
  • UPC 019532714578
  • UPC 019348982703
  • UPC 019348925761
  • UPC 019532711653
  • UPC 019532727931
  • UPC 019532717268
  • UPC 019348976395
  • UPC 019348982234
  • UPC 019532702826
  • UPC 019532727464
  • UPC 019348927371
  • UPC 019532718421
  • UPC 019348988536
  • UPC 088438965007
  • UPC 019532708492
  • UPC 019532708642
  • UPC 019532704917
  • UPC 019348987684
  • UPC 019532707556
  • UPC 088994276032
  • UPC 019348998164
  • UPC 019348998969
  • UPC 019348999018
  • UPC 019348930066
  • UPC 019348982123
  • UPC 019532702884
  • UPC 019532712395
  • UPC 019532731496
  • UPC 019348934891
  • UPC 019348954552
  • UPC 019348929236
  • UPC 019348936535
  • UPC 019532727358
  • UPC 019348938052
  • UPC 019348986037
  • UPC 019532708412
  • UPC 019532724504
  • UPC 019348982021
  • UPC 019532709042
  • UPC 019532702147
  • UPC 019532704590
  • UPC 019532721878
  • UPC 019532726705
  • UPC 019348920157
  • UPC 019532722354
  • UPC 019348978611
  • UPC 019532712656
  • UPC 019532727261
  • UPC 019348935833
  • UPC 019348994665
  • UPC 019348995958
  • UPC 019348992627
  • UPC 019532713557
  • UPC 019348939123
  • UPC 088994290385
  • UPC 019348929631
  • UPC 019348931018
  • UPC 019348944277
  • UPC 019532724262
  • UPC 019348991514
  • UPC 019348921874
  • UPC 019348986337
  • UPC 019348970120
  • UPC 019348997971
  • UPC 019348941129
  • UPC 019348939820
  • UPC 019532724004
  • UPC 019532726860
  • UPC 019348990421
  • UPC 019532708278
  • UPC 019348919179
  • UPC 019348973825
  • UPC 019348981280
  • UPC 019348934329
  • UPC 019348994725
  • UPC 019348959033
  • UPC 019532720300
  • UPC 019532717124
  • UPC 019348991971
  • UPC 088994278935
  • UPC 019348981293
  • UPC 019348924185
  • UPC 019348984199
  • UPC 019348921152
  • UPC 019532714892
  • UPC 019348982501
  • UPC 019348982050
  • UPC 019532710364
  • UPC 019532720540
  • UPC 019348927536
  • UPC 019348991972
  • UPC 019348941739
  • UPC 019532708279
  • UPC 019348932867
  • UPC 019532709169
  • UPC 019532722471
  • UPC 019532726638
  • UPC 019532717172
  • UPC 019348926846
  • UPC 019348985640
  • UPC 019532730242
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 9,555 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.

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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