Hearth Record

Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B

Medical device recall Z-2634-2024. Published in FDA’s Enforcement Report on Sep 4, 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 4, 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) PAIN SERVICES CDS , Pack Number CDS985445B ; 2) PAIN SERVICES CDS , Pack Number CDS985445C ; 3) PAIN TRAY , Pack Number DYNDA1233B ; 4) PAIN TRAY , Pack Number DYNDA2402A ; 5) C ARM BLOCK PACK, Pack Number DYNDA2795; 6) SINGLE DOSE EPI TRAY, Pack Number DYNDA2965; 7) MAMMOGRAPHY TRAY, Pack Number DYNDH1094; 8) FTMC PAIN TRAY, Pack Number DYNDH1239D; 9) LUMBAR PUNCTURE - CHLORAPREP, Pack Number DYNDH1351B ; 10) PAIN MANAGEMENT PACK, Pack Number DYNDH1697; 11) PAIN MANAGEMENT PACK, Pack Number DYNDH1697A ; 12) EPIDURAL TRAY , Pack Number DYNDH1739; 13) PAIN MANAGEMENT TRAY, Pack Number DYNDH1823; 14) PAIN KIT MARSHFIELD , Pack Number DYNDH1842; 15) PAIN TRAY , Pack Number DYNDH1938; 16) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290C ; 17) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290D ; 18) PAIN SERVICE PACK-LF, Pack Number DYNJ0101290F ; 19) MANAGEMENT PAIN PACK-LF , Pack Number DYNJ0377378G ; 20) MANAGEMENT PAIN PACK-LF , Pack Number DYNJ0377378I ; 21) STERILE PAIN PACK-LF, Pack Number DYNJ0384670F ; 22) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265G ; 23) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265I ; 24) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265J ; 25) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265K ; 26) EPIDURAL PAIN INJ (O.I) PK-LF , Pack Number DYNJ0429265L ; 27) EPIDURAL PAIN INJ (O.I) PK-LF, Pack Number DYNJ0429265M; 28) PANCREAS DONOR PACK-LF, Pack Number DYNJ0429318F ; 29) MINOR ACUTE PACK-LF , Pack Number DYNJ0484979C ; 30) STANDARD BIOPSY PACK-LF , Pack Number DYNJ0487701G ; 31) LOCAL PACK-LF , Pack Number DYNJ0554526I ; 32) ESI PACK-LF , Pack Number DYNJ0562716G ; 33) PAIN MANAGEMENT - EDOC PACK-LF, Pack Number DYNJ0625993I; 34) BGMC MJR ORAL/MAXILLO PACK-LF , Pack Number DYNJ0664646B ; 35) FREE FLAP RECIPIENT PACK-LF , Pack Number DYNJ0773964J ; 36) FREE FLAP RECIPIENT PACK-LF , Pack Number DYNJ0773964K ; 37) FREE FLAP RECIPIENT PACK-LF , Pack Number DYNJ0773964L ; 38) DSA PACK-LF , Pack Number DYNJ0843713D ; 39) STANDARD BIOPSY PACK-LF , Pack Number DYNJ0904575C ; 40) LOCALS PACK-LF, Pack Number DYNJ0939707; 41) EP TRAY , Pack Number DYNJ21808D ; 42) PAIN MANAGEMENT , Pack Number DYNJ26879B ; 43) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384L ; 44) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384M ; 45) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384N ; 46) PAIN MANAGEMENT MINOR-LF, Pack Number DYNJ28384O ; 47) FACET , Pack Number DYNJ28549D ; 48) PAIN MANAGEMENT PACK, Pack Number DYNJ30042A ; 49) PAIN MANAGEMENT KIT , Pack Number DYNJ30500; 50) PAIN MANAGEMENT KIT , Pack Number DYNJ30500A ; 51) PAIN BLOCKS PACK, Pack Number DYNJ31717B ; 52) PAIN BLOCKS PACK, Pack Number DYNJ31717C ; 53) PAIN BLOCKS PACK, Pack Number DYNJ31717D ; 54) RADIOLOGY EPIDURAL 0906005-LF , Pack Number DYNJ32775K ; 55) UNIVERSAL BLOCK TRAY;EXT LINE , Pack Number DYNJ33057; 56) CONTINUOUS EPIDURAL TRAY-LF , Pack Number DYNJ34352B ; 57) CONTINUOUS EPIDURAL TRAY-LF , Pack Number DYNJ34352C ; 58) LOCAL BASIC , Pack Number DYNJ34418I ; 59) LOCAL BASIC , Pack Number DYNJ34418L ; 60) LOCAL BASIC , Pack Number DYNJ34418M ; 61) PATIENT PREP TRAY , Pack Number DYNJ34489D ; 62) SOFT PAIN TRAY-LF , Pack Number DYNJ35270C ; 63) PAIN MANAGEMENT , Pack Number DYNJ36528A ; 64) PAIN MANAGEMENT , Pack Number DYNJ36528B ; 65) LOCAL PROCEDURE PACK, Pack Number DYNJ38148C ; 66) LOCAL PROCEDURE PACK, Pack Number DYNJ38148D ; 67) BASIC PAIN PACK-LF, Pack Number DYNJ38623F ; 68) BASIC PAIN PACK-LF, Pack Number DYNJ38623G ; 69) BASIC PAIN PACK-LF, Pack Number DYNJ38623I; 70) SINGLE DOSE EPIDURAL TRAY-LF, Pack Number DYNJ39178B ; 71) PAIN PROCEDURE PACK , Pack Number DYNJ40804D ; 72) BLOCK PACK, Pack Number DYNJ44205B ; 73) BLOCK PACK, Pack Number DYNJ44205D ; 74) EP PACK 319704, Pack Number DYNJ44602C ; 75) PAIN PACK , Pack Number DYNJ45913A ; 76) PAIN PACK , Pack Number DYNJ45913B ; 77) PAIN PACK , P

1,679,067 units in total, in FDA’s words.

Source:

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

Codes to check against yours

CDS985445B , Lot Number 19ABK040 ; CDS985445B , Lot Number 19ABV498 ; CDS985445B , Lot Number 19BBN825 ; CDS985445B , Lot Number 19EBG359 ; CDS985445B , Lot Number 19FBA393 ; CDS985445B , Lot Number 19GBC446 ; CDS985445B , Lot Number…

Every code shown here, 1,992 characters

CDS985445B , Lot Number 19ABK040 ; CDS985445B , Lot Number 19ABV498 ; CDS985445B , Lot Number 19BBN825 ; CDS985445B , Lot Number 19EBG359 ; CDS985445B , Lot Number 19FBA393 ; CDS985445B , Lot Number 19GBC446 ; CDS985445B , Lot Number 19HBM036 ; CDS985445B , Lot Number 19JBS476 ; CDS985445B , Lot Number 19LBC804 ; CDS985445B , Lot Number 20BBA618 ; CDS985445B , Lot Number 20CBI761 ; CDS985445B , Lot Number 20DBM201 ; CDS985445B , Lot Number 21ABX275 ; CDS985445B , Lot Number 21CBG480 ; CDS985445B , Lot Number 21CBV955 ; CDS985445B , Lot Number 21DBQ516 ; CDS985445C , Lot Number 21IBP827 ; CDS985445C , Lot Number 21KBO008 ; CDS985445C , Lot Number 22BBK102 ; CDS985445C , Lot Number 22OBI304 ; CDS985445C , Lot Number 22EBI120 ; CDS985445C , Lot Number 22GBP605 ; CDS985445C , Lot Number 22GBU597 ; CDS985445C , Lot Number 22GBY036 ; CDS985445C , Lot Number 22HMG268 ; CDS985445C , Lot Number 22HMH893 ; CDS985445C , Lot Number 22JME066 ; CDS985445C , Lot Number 22KMC551 ; CDS985445C , Lot Number 22LMA461 ; CDS985445C , Lot Number 22LMC730 ; CDS985445C , Lot Number 23AMG434 ; CDS985445C , Lot Number 23FMC235 ; CDS985445C , Lot Number 23GME307 ; CDS985445C , Lot Number 23JMF730 ; DYNDA1233B , Lot Number 21JBQ010 ; DYNDA2402A , Lot Number 22JBE471 ; DYNDA2402A , Lot Number 22JBH025 ; DYNDA2402A , Lot Number 22KBU699 ; DYNDA2402A , Lot Number 23ABN842 ; DYNDA2402A , Lot Number 23CBM334 ; DYNDA2402A , Lot Number 23EBS527 ; DYNDA2402A , Lot Number 23HBL655 ; DYNDA2402A , Lot Number 23HBZ380 ; DYNDA2402A , Lot Number 23IBO904 ; DYNDA2402A , Lot Number 23KBE880 ; DYNDA2795, Lot Number 24DMD278; DYNDA2795, Lot Number 21HBS958 ; DYNDA2965, Lot Number 23JBE036; DYNDH1094, Lot Number 22NBD305 ; DYNDH1094, Lot Number 22DBE033 ; DYNDH1094, Lot Number 20ABB780 ; DYNDH1094, Lot Number 21DBO182 ; DYNDH1239D, Lot Number 23LBM683; DYNDH1239D, Lot Number 23IBP933; DYNDH1239D, Lot Number 23GBM258; DYNDH1239D, Lot Number 23FBI290; DYNDH1239D, Lot Number 23EBQ559; DYNDH1239D, Lot Number…

FDA’s list runs to 610,394 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 Aug 28, 2024.
  • FDA’s Enforcement Report published it on Sep 4, 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 610,394 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.

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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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