Hearth Record

Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115

Medical device recall Z-3059-2024. Published in FDA’s Enforcement Report on Sep 18, 2024.

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 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.

Source:

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.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115; 2) NICU CNTRL LINE BLOOD DRAW KIT, Pack Number DYLAB1044; 3) NEURO ANGIO PACK, Pack Number DYNDA1431A; 4) BLOOD WITHDRAWAL KIT #2, Pack Number DYNDA1683A; 5) LCPH LAB DRAW KIT , Pack Number DYNDH1641A ; 6) LCPH LAB DRAW KIT , Pack Number DYNDH1641AH; 7) INFUSION CENTER BLOOD DRAW KIT, Pack Number DYNDH1798; 8) BLOOD CULTURE, Pack Number DYNDH1921; 9) BLOOD WITHDRAWAL TRAY, Pack Number DYNDV1588F; 10) BLOOD WITHDRAWAL TRAY , Pack Number DYNDV1588G ; 11) PHLEBECTOMY PK, Pack Number DYNJ84749; 12) ARTHROGRAPH TRAY, Pack Number MNS12670A; 13) BLOOD CULTURE COLLECTION KIT, Pack Number MNS8915; 14) BLOOD CULTURE COLLECTION KIT, Pack Number MNS8915H ; 15) LACERATION TRAY, Pack Number SUT20955

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

BP115, Lot Number 21BBG338 ; BP115, Lot Number 21CBE353 ; BP115, Lot Number 21CBJ050 ; DYLAB1044, Lot Number 23GBM782 ; DYNDA1431A, Lot Number 2020012890; DYNDA1683A, Lot Number 2019011790; DYNDA1683A, Lot Number 2019032590; DYNDA1683A,…

Every code shown here, 1,994 characters

BP115, Lot Number 21BBG338 ; BP115, Lot Number 21CBE353 ; BP115, Lot Number 21CBJ050 ; DYLAB1044, Lot Number 23GBM782 ; DYNDA1431A, Lot Number 2020012890; DYNDA1683A, Lot Number 2019011790; DYNDA1683A, Lot Number 2019032590; DYNDA1683A, Lot Number 2019042390; DYNDA1683A, Lot Number 2019072390; DYNDA1683A, Lot Number 2019090990; DYNDA1683A, Lot Number 2019102390; DYNDA1683A, Lot Number 2019112290; DYNDA1683A, Lot Number 2020030990; DYNDH1641A , Lot Number 21JBE248 ; DYNDH1641A , Lot Number 21JBY828 ; DYNDH1641AH, Lot Number 21JBE248 ; DYNDH1641AH, Lot Number 21JBY828 ; DYNDH1798, Lot Number 2022112990; DYNDH1921, Lot Number 23KBC196; DYNDV1588F, Lot Number 2019022090; DYNDV1588F, Lot Number 2019041890; DYNDV1588F, Lot Number 2019090390; DYNDV1588F, Lot Number 2020012890; DYNDV1588G , Lot Number 22GBL908 ; DYNDV1588G , Lot Number 22HBN586 ; DYNDV1588G , Lot Number 22JBI927 ; DYNDV1588G , Lot Number 22LBK218 ; DYNDV1588G , Lot Number 23ABJ940 ; DYNDV1588G , Lot Number 23EBB512 ; DYNDV1588G , Lot Number 23EBU397 ; DYNDV1588G , Lot Number 23IBU991 ; DYNDV1588G , Lot Number 23KBS797 ; DYNJ84749, Lot Number 23HBE651 ; DYNJ84749, Lot Number 23JBD780 ; MNS12670A, Lot Number 2022112990; MNS8915, Lot Number 21GBS360 ; MNS8915, Lot Number 21HBU417 ; MNS8915, Lot Number 21JBI844 ; MNS8915, Lot Number 21JBY844 ; MNS8915, Lot Number 21LBO003 ; MNS8915, Lot Number 21LBS501 ; MNS8915, Lot Number 22CBY070 ; MNS8915, Lot Number 22HBA169 ; MNS8915, Lot Number 22HBT299 ; MNS8915, Lot Number 22IBR400 ; MNS8915, Lot Number 22KBV233 ; MNS8915, Lot Number 23ABF223 ; MNS8915, Lot Number 23CBT546 ; MNS8915, Lot Number 23DBA141 ; MNS8915, Lot Number 23EBF405 ; MNS8915, Lot Number 23FBF145 ; MNS8915, Lot Number 23GBH740 ; MNS8915, Lot Number 23IBL050 ; MNS8915, Lot Number 23JBK017 ; MNS8915, Lot Number 23LBE535 ; MNS8915, Lot Number 24ABQ710 ; MNS8915H , Lot Number 21GBS360 ; MNS8915H , Lot Number 21HBU417 ; MNS8915H , Lot Number 21JBI844 ; MNS8915H , Lot Number 21JBY844 ; MNS8915H , Lot…

FDA’s list runs to 2,571 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.

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.

Source:

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.

Source:

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.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 2,571 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.

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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.

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