Hearth Record

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

Medical device recall Z-2321-2023. 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. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B; b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A; c. PERC PACK-LF, Model Number: DYNJ0774759P; d. PERCUTANEOUS VASCULAR CDS, Model Number: DYNJ902261D; e. PERIPHERAL NERVE BLOCK KIT/P, Model Number: DYNJRA1747; f. PERIPHERAL PACK, Model Number: DYNJ44960D; g. PERIPHERAL ULTRASOUND CATHETER, Model Number: DYNDV2285, MNS9865; h. PERIPHERAL VASCULAR GRAFT PACK, Model Number: DYNJ904401B; i. PERMACATH-LF, Model Number: DYNJ42262D; j. PHLEBECTOMY PACK, Model Number: DYNJ47502B; k. PHYSIATRY PACK, Model Number: DYNJ67414; l. PICC INSERT KIT-LESS THAN 3 FR, Model Number: PHS41739A; m. PICC INSERTION PACK, Model Number: DYNJ60038; n. PICC LINE DOUBLE LUMEN CDS, Model Number: CDS982858F; o. PICC LINE INSERTION, Model Number: DYNJ39885A; p. PICC LINE INSERTION WRO-LF, Model Number: DYNJ41873B; q. PICC LINE TRAY, Model Number: DYNJ52688A; r. PICC LINE TRIPLE LUMEN CDS, Model Number: CDS982859F; s. PICC LINEPACK (PCLUI)642-LF, Model Number: DYNJ47717; t. PICC PACK, Model Number: DYNJ55723A, DYNJ60990; u. PICC PROCEDURE PACK, Model Number: DYNJ59067; v. PICC TRAY, Model Number: DYNJ49177F; w. PIV WITH ULTRASOUND KIT, Model Number: DYNDC2399A; x. PK GEN-RECIPIENT, Model Number: DYNJ41114C; y. PK GEN-TRANSPLANT, Model Number: DYNJ54894A; z. PK, GEN-TRANSPLANT, Model Number: DYNJ54894A; aa. PK, GEN-TRANSPLANT-DONOR, Model Number: DYNJ54982A; bb. PORT INSERTION PACK, Model Number: CVI4765; cc. PORT PACK, Model Number: DYNJ56857B, DYNJ68990; dd. POWERGLIDE PLACEMENT KIT, Model Number: DYNDA1468C; ee. PREMIER PROCEDURE PACK, Model Number: DYNJ64393; ff. PREP KIT, Model Number: DYNJRA1155B, DYNJRA1200B; gg. PREP TRAY, Model Number: DYNJRA1498; hh. PROCEDURE PACK, Model Number: DYNJ55063A, DYNJ57674A, DYNJ59795A, DYNJ62588, DYNJ64372, DYNJ64372A, DYNJ68968; ii. PUH AV FISTULA CDS, Model Number: CDS984329J; jj. PURPLE PACK, Model Number: DYNJ62197; kk. PV INTERVENTIONAL PACK-LF, Model Number: DYNJ45757F; ll. PV PACK, Model Number: DYNJ46549J; mm. RAD CVC TRAY, Model Number: DYNJ35574A, DYNJ54131; nn. RAD ONC LITHOTOMY PACK, Model Number: DYNJ60698B; oo. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ63155A; pp. RADIOLOGY PACK, Model Number: DYNJ42172A; qq. RADIOLOGY PACK-LF #108402, Model Number: DYNJ58225B; rr. RADIOLOGY SPECIALS PACK, Model Number: PHS479840M; ss. RADIOLOGY TRAY, Model Number: MNS11625; tt. RECIPIENT PACK, Model Number: DYNJ41114B; uu. REGIONAL SINGLE SHOT KIT, Model Number: DYNJRA1256; vv. RFA PACK, Model Number: DYNJ57149, DYNJ67899; ww. RIGHT HEART TRAY, Model Number: DYNJ40379C; xx. ROBOT, Model Number: DYNJ906112; yy. ROBOTIC GYN SSC, Model Number: DYNJ60009A; zz. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826B, DYNJ905826C, DYNJ905826D, DYNJ905826F; aaa. RRMC AORTIC GRAFT PACK-2, Model Number: DYNJ33546J; bbb. RR-SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0785821M, DYNJ0785821N, DYNJ0785821O; ccc. SCLEROTHERAPY KIT, Model Number: DYNJ62434A; ddd. SLUH LIVER TRANSPLANT PACK-LF, Model Number: DYNJ0369434M; eee. SMH VASCULAR CDS, Model Number: CDS984584L; fff. SPECIAL PROCEDURE PACK, Model Number: DYNJ53135B, DYNJ53135C; ggg. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535U, DYNJ0416535Y; hhh. SPECIALS PACK, Model Number: DYNJ67504A; iii. SPECIALS TRACE PACK, Model Number: DYNJ57303A, DYNJ57303B; jjj. SSC GU ROBOTIC PACK, Model Number: DYNJ64027; kkk. ST CHARLES PORT PACK, Model Number: DYNJ49833J; lll. STERILE INJECTION PACK, Model Number: DYNDA2805; mmm. SUPPORT TRAY W/CHLORAPREP, Model Number: DYNJRA0958; nnn. SVMMC AV FISTULA PACK, Model Number: DYNJ48153C; ooo. SVMMC VASCULAR MAJOR PA

233,638 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: DYNJ54755B, UPC Number: 088994292536. b. Model Number: DYNJ40306A, UPC Number: 088994260192. c.…

Every code shown here, 1,996 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: DYNJ54755B, UPC Number: 088994292536. b. Model Number: DYNJ40306A, UPC Number: 088994260192. c. Model Number: DYNJ0774759P, UPC Number: 019532724613. d. Model Number: DYNJ902261D, UPC Number: 088994275524. e. Model Number: DYNJRA1747, UPC Number: 019348946400. f. Model Number: DYNJ44960D, UPC Number: 019348983324. g. Model Number: DYNDV2285, UPC Number: 019348919454; Model Number: MNS9865, UPC Number: 065316029443. h. Model Number: DYNJ904401B, UPC Number: 019348968343. i. Model Number: DYNJ42262D, UPC Number: 088994269795. j. Model Number: DYNJ47502B, UPC Number: 019348964922. k. Model Number: DYNJ67414, UPC Number: 019348996464. l. Model Number: PHS41739A, UPC Number: 088994290680. m. Model Number: DYNJ60038, UPC Number: 088827779327. n. Model Number: CDS982858F, UPC Number: 088827773921. o. Model Number: DYNJ39885A, UPC Number: 088994253993. p. Model Number: DYNJ41873B, UPC Number: 019348956306. q. Model Number: DYNJ52688A, UPC Number: 088994284356. r. Model Number: CDS982859F, UPC Number: 088827773920. s. Model Number: DYNJ47717, UPC Number: 088827751458. t. Model Number: DYNJ55723A, UPC Number: 088994286553; Model Number: DYNJ60990, UPC Number: 019348953847. u. Model Number: DYNJ59067, UPC Number: 088994293004. v. Model Number: DYNJ49177F, UPC Number: 088827777434. w. Model Number: DYNDC2399A, UPC Number: 088994244693. x. Model Number: DYNJ41114C, UPC Number: 019532726173. y. Model Number: DYNJ54894A, UPC Number: 019348921355. z. Model Number: DYNJ54894A, UPC Number: 019348921355. aa. Model Number: DYNJ54982A, UPC Number: 019348980895. bb. Model Number: CVI4765, UPC Number: 019348995318. cc. Model Number: DYNJ56857B, UPC Number: 019348989314; Model Number: DYNJ68990, UPC Number: 019348987261. dd. Model Number: DYNDA1468C, UPC Number: 088994284317; Model Number: DYNDA1468C, UPC Number: 10889942843176. ee. Model Number:…

FDA’s list runs to 9,466 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 088994292536
  • UPC 088994260192
  • UPC 019532724613
  • UPC 088994275524
  • UPC 019348946400
  • UPC 019348983324
  • UPC 019348919454
  • UPC 065316029443
  • UPC 019348968343
  • UPC 088994269795
  • UPC 019348964922
  • UPC 019348996464
  • UPC 088994290680
  • UPC 088827779327
  • UPC 088827773921
  • UPC 088994253993
  • UPC 019348956306
  • UPC 088994284356
  • UPC 088827773920
  • UPC 088827751458
  • UPC 088994286553
  • UPC 019348953847
  • UPC 088994293004
  • UPC 088827777434
  • UPC 088994244693
  • UPC 019532726173
  • UPC 019348921355
  • UPC 019348980895
  • UPC 019348995318
  • UPC 019348989314
  • UPC 019348987261
  • UPC 088994284317
  • UPC 10889942843176
  • UPC 019348980963
  • UPC 019348958371
  • UPC 019348956827
  • UPC 019348979574
  • UPC 019348968054
  • UPC 088827777174
  • UPC 019348956698
  • UPC 019348966983
  • UPC 019348980722
  • UPC 019348988468
  • UPC 019348987039
  • UPC 088994286535
  • UPC 019348963300
  • UPC 088827779258
  • UPC 019348933778
  • UPC 088438953806
  • UPC 088994246680
  • UPC 019532706789
  • UPC 019348931402
  • UPC 019348950271
  • UPC 088827777898
  • UPC 019348968272
  • UPC 065316032213
  • UPC 088994269269
  • UPC 019348951155
  • UPC 088994272160
  • UPC 019348945449
  • UPC 088994281455
  • UPC 019348965663
  • UPC 019348964887
  • UPC 019348978095
  • UPC 019348940758
  • UPC 019532702352
  • UPC 019532721705
  • UPC 019348956435
  • UPC 019532726373
  • UPC 019348936627
  • UPC 019532729542
  • UPC 088994270130
  • UPC 019348966082
  • UPC 019348946843
  • UPC 019532700961
  • UPC 088827778321
  • UPC 019348936064
  • UPC 019348977993
  • UPC 019532705946
  • UPC 019348984614
  • UPC 088994261890
  • UPC 088994276562
  • UPC 088994291573
  • UPC 019348929531
  • UPC 019348984061
  • UPC 019348963449
  • UPC 019348974116
  • UPC 019348981688
  • UPC 088994249424
  • UPC 019532704487
  • UPC 088994285183
  • UPC 088994294165
  • UPC 081698202335
  • UPC 081698202337
  • UPC 019532722356
  • UPC 019348958303
  • UPC 10653160344353
  • UPC 019532718408
  • UPC 088827729567
  • UPC 088994265334
  • UPC 088994279547
  • UPC 019532729876
  • UPC 065316099015
  • UPC 019348947673
  • UPC 019348991983
  • UPC 065316030766
  • UPC 065316099305
  • UPC 065316034231
  • UPC 019348943086
  • UPC 019348944347
  • UPC 019348923168
  • UPC 10889942277360
  • UPC 065316099026
  • UPC 019532701409
  • UPC 088994251983
  • UPC 019348944003
  • UPC 088438972552
  • UPC 10889942519835
  • UPC 019348956517
  • UPC 019348981007
  • UPC 019348994641
  • UPC 019532703956
  • UPC 019348943446
  • UPC 088994225654
  • UPC 088994220768
  • UPC 088994225559
  • UPC 019348954775
  • UPC 019532717689
  • UPC 019348930511
  • UPC 019348931744
  • UPC 019348954925
  • UPC 088438991665
  • UPC 088994256499
  • UPC 088994293350
  • UPC 019532707200
  • UPC 088438909956
  • UPC 088827775768
  • UPC 019348943563
  • UPC 088994288526
  • UPC 088994289719
  • UPC 088994287340
  • UPC 019348954814
  • UPC 088827777552
  • UPC 019348955447
  • UPC 088827776402
  • UPC 088994270850
  • UPC 088827777970
  • UPC 019348959856
  • UPC 019348956982
  • UPC 019348931726
  • UPC 019348953951
  • UPC 088827776729
  • UPC 088994257453
  • UPC 019532702466
  • UPC 088994264067
  • UPC 019532726140
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 9,466 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.

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

1 of 4

Every fact names its source.

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

Sign in

A free account keeps your watch list, shortlists, comparisons and saved searches on every device, and can email you when something you watch changes. Browsing never needs one.