Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915
Medical device recall Z-3021-2024. Published in FDA’s Enforcement Report on Sep 18, 2024.
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 Sep 18, 2024. 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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915; 2) PORT ACCESS TRAY, Pack Number DYNDC1318D; 3) KNEE ARTHROSCOPY PACK-LF, Pack Number DYNJ0101308C ; 4) UNIVERSAL PLASTIC , Pack Number DYNJ04047C ; 5) JAM CATH LAB MINOR PACK , Pack Number DYNJ17507B ; 6) STARTER PACK CMH-LF , Pack Number DYNJ41737C ; 7) DELIVERY PACK ME-LF , Pack Number DYNJ45589B ; 8) STERILE STARTER SET PACK, Pack Number DYNJ47814; 9) IVF PACK, Pack Number DYNJ63783; 10) VI PACK , Pack Number DYNJ64811; 11) VI PACK , Pack Number DYNJ64871; 12) IR CENTRAL KIT, Pack Number DYNJ68285; 13) PICC KIT 4F SL PL MAX BARRIER, Pack Number PICC0011; 14) PICC KIT 4F SL PL MAX BARRIER, Pack Number PICC0012; 15) LACERATION TRAY, Pack Number SUT20955; 16) UMBILICAL VESSEL TRAY, Pack Number UVT1100A; 17) UMBILICAL INSERTION W/3.5 CATH, Pack Number UVT1225; 18) UMBILICAL INSERTION W/3.5 CATH, Pack Number UVT1225H ; 19) UMBILICAL TRAY W/3.5&5FR CATH , Pack Number UVT1250H
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CVI4915, Lot Number 2022103180; DYNDC1318D, Lot Number 2019012590; DYNJ0101308C , Lot Number 19BKC672 ; DYNJ04047C , Lot Number 21FBN548 ; DYNJ04047C , Lot Number 21GBL027 ; DYNJ04047C , Lot Number 21IBX365 ; DYNJ04047C , Lot Number…
Every code shown here, 1,994 characters
CVI4915, Lot Number 2022103180; DYNDC1318D, Lot Number 2019012590; DYNJ0101308C , Lot Number 19BKC672 ; DYNJ04047C , Lot Number 21FBN548 ; DYNJ04047C , Lot Number 21GBL027 ; DYNJ04047C , Lot Number 21IBX365 ; DYNJ04047C , Lot Number 22ABM052 ; DYNJ04047C , Lot Number 19ABD460 ; DYNJ04047C , Lot Number 22CBP491 ; DYNJ04047C , Lot Number 22OBI898 ; DYNJ04047C , Lot Number 19FBD994 ; DYNJ04047C , Lot Number 22IBH860 ; DYNJ04047C , Lot Number 22IBJ054 ; DYNJ04047C , Lot Number 22LBR925 ; DYNJ04047C , Lot Number 19VBB656 ; DYNJ04047C , Lot Number 23ABS681 ; DYNJ04047C , Lot Number 19KBC727 ; DYNJ04047C , Lot Number 19KBF911 ; DYNJ04047C , Lot Number 20DBF312 ; DYNJ04047C , Lot Number 20JBC775 ; DYNJ17507B , Lot Number 19JDB044 ; DYNJ17507B , Lot Number 20EDA752 ; DYNJ17507B , Lot Number 20FDB395 ; DYNJ17507B , Lot Number 20IDB921 ; DYNJ17507B , Lot Number 20JDA956 ; DYNJ17507B , Lot Number 20LDB169 ; DYNJ17507B , Lot Number 21GDA031 ; DYNJ17507B , Lot Number 21HDB179 ; DYNJ17507B , Lot Number 21JDC732 ; DYNJ17507B , Lot Number 23ADA442 ; DYNJ41737C , Lot Number 21FBK597 ; DYNJ41737C , Lot Number 21GBM874 ; DYNJ41737C , Lot Number 21IBD142 ; DYNJ41737C , Lot Number 21JBB598 ; DYNJ41737C , Lot Number 21JBB602 ; DYNJ41737C , Lot Number 21WBA194 ; DYNJ41737C , Lot Number 21LBP147 ; DYNJ41737C , Lot Number 22ABE433 ; DYNJ41737C , Lot Number 19ABJ657 ; DYNJ41737C , Lot Number 19CBB947 ; DYNJ41737C , Lot Number 22OBI031 ; DYNJ41737C , Lot Number 19CBO914 ; DYNJ41737C , Lot Number 19DBC698 ; DYNJ41737C , Lot Number 19DBO702 ; DYNJ41737C , Lot Number 22FBJ538 ; DYNJ41737C , Lot Number 19RBC166 ; DYNJ41737C , Lot Number 22HBV259 ; DYNJ41737C , Lot Number 19SBB262 ; DYNJ41737C , Lot Number 22JBK898 ; DYNJ41737C , Lot Number 19IBB771 ; DYNJ41737C , Lot Number 19IBE072 ; DYNJ41737C , Lot Number 19JBE636 ; DYNJ41737C , Lot Number 19LBT637 ; DYNJ41737C , Lot Number 20CBC820 ; DYNJ41737C , Lot Number 23GBF976 ; DYNJ41737C , Lot Number 23HBE132 ; DYNJ41737C , Lot Number 20EBD652 ;…
FDA’s list runs to 4,315 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 8, 2024.
- FDA classified it on Sep 6, 2024.
- FDA’s Enforcement Report published it on Sep 18, 2024.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 4,315 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.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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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.
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.