Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645
Medical device recall Z-3029-2024. 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) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 2) PICU LINE TRAY, Pack Number DYNDC1960A; 3) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 4) MINI INTERVENTIONAL PACK, Pack Number DYNDH1324A; 5) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNDH1514; 6) BIOPSY KIT, Pack Number DYNDH1570; 7) MYELOGRAM TRAY, Pack Number DYNDH1574; 8) BONE MARROW ASPIRATION AND BIOPSY, Pack Number DYNDH1596; 9) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNDH1638; 10) BIOPSY PACK, Pack Number DYNDH1699; 11) LACERATION TRAY, Pack Number DYNDL1159B; 12) SUTURE TRAY, Pack Number DYNDS1064B; 13) BONE MARROW BIOPSY ASPIRATION, Pack Number DYNJTS0214; 14) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 15) PEDI ULTRASOUND GUIDED PIV KIT, Pack Number IVS3320; 16) ARTHROGRAM PACK, Pack Number P241108; 17) PACK BONE MARROW BIOPSY, Pack Number P268481; 18) BIOPSY BASIC PACK, Pack Number P784604; 19) ARTHROGRAM TRAY-LF, Pack Number SPEC0061B; 20) BIOPSY TRAY, Pack Number SPEC0095; 21) RADIOLOGY/BIOPSY, Pack Number SPEC0149; 22) BONE MARROW TRAY, Pack Number SPEC0255; 23) ARTHROGRAM TRAY-LF, Pack Number SPEC0400
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
DM645, Lot Number 2019120980; DYNDC1960A, Lot Number 2022040790; DYNDH1319, Lot Number 2020122250; DYNDH1324A, Lot Number 2020122250; DYNDH1514, Lot Number 2020040250; DYNDH1514, Lot Number 2020050750; DYNDH1570, Lot Number 2022011450;…
Every code shown here, 1,593 characters
DM645, Lot Number 2019120980; DYNDC1960A, Lot Number 2022040790; DYNDH1319, Lot Number 2020122250; DYNDH1324A, Lot Number 2020122250; DYNDH1514, Lot Number 2020040250; DYNDH1514, Lot Number 2020050750; DYNDH1570, Lot Number 2022011450; DYNDH1574, Lot Number 2022011450; DYNDH1596, Lot Number 2020122250; DYNDH1596, Lot Number 2022092090; DYNDH1638, Lot Number 2021062150; DYNDH1638, Lot Number 2021092350; DYNDH1638, Lot Number 2022011450; DYNDH1638, Lot Number 2022060750; DYNDH1699, Lot Number 2022060750; DYNDL1159B, Lot Number 2019022580; DYNDS1064B, Lot Number 2019062480; DYNDS1064B, Lot Number 2019120980; DYNJTS0214, Lot Number 2020113050; DYNJTS0214, Lot Number 2021012850; DYNJTS0214, Lot Number 2021050750; DYNJTS0214, Lot Number 2021082650; DYNJTS0214, Lot Number 2021102550; DYNJTS0214, Lot Number 2021111290; DYNJTS0214, Lot Number 2022040790; DYNJTS0214, Lot Number 2022052690; DYNJTS0214, Lot Number 2022080390; DYNJTS0214, Lot Number 2022092090; DYNJTS0214, Lot Number 2022102190; DYNJTS0214, Lot Number 2023100990; DYNJTS0214, Lot Number 2024010890; DYNJTS4306, Lot Number 2022011450; IVS3320, Lot Number 2021111290; P241108, Lot Number 2021012850; P268481, Lot Number 2022060750; P784604, Lot Number 2019120980; SPEC0061B, Lot Number 2021062150; SPEC0095, Lot Number 2020113050; SPEC0095, Lot Number 2022060750; SPEC0149, Lot Number 2020113050; SPEC0255, Lot Number 2019022580; SPEC0255, Lot Number 2019032580; SPEC0255, Lot Number 2019062480; SPEC0255, Lot Number 2019120980; SPEC0255, Lot Number 2019121080; SPEC0255, Lot Number 2020012080; SPEC0400, Lot Number 2020113050
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.”
- 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.