Z-3054-2024.jsonld
type: Dataset
name: Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack Number CDS940242I ; 3) ARTHROSCOPY-LF, Pack Number CDS940859J ; 4) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS940869U ; 5) ARTHROSCOPY CDS , Pack Number CDS940960I ; 6) ARTHROSCOPY CDS , Pack Number CDS941059L ; 7) ARTHROSCOPY CDS , Pack Number CDS941062K ; 8) ARTHROSCOPY CDS , Pack Number CDS941110L ; 9) ARTHROSCOPY , Pack Number CDS980751I ; 10) ARTHROSCOPY CDS , Pack Number CDS980893; 11) SHOULDER ARTHROSCOPY CDS-LF , Pack Number CDS981003K ; 12) ARTHROSCOPY CDS , Pack Number CDS981011B ; 13) ARTHROSCOPY PROCEDURE , Pack Number CDS981660J ; 14) SHOULDER ARTHROSCOPY CDS, Pack Number CDS982199G ; 15) ARTHROSCOPY CDS , Pack Number CDS982216C ; 16) ARTHROSCOPY CDS-LF, Pack Number CDS982232F ; 17) ARMC ARTHROSCOPY CDS, Pack Number CDS982278K ; 18) ASC SHOULDER ARTHRO CDS SRM-LF, Pack Number CDS982536C ; 19) ARTHROSCOPY PACK, Pack Number CDS982560D ; 20) ARTHROSCOPY CDS , Pack Number CDS982645J ; 21) ARTHROSCOPY CDS-LF, Pack Number CDS982757D ; 22) ARTHROSCOPY CDS , Pack Number CDS983102F ; 23) ARTHROSCOPY CDS-LF, Pack Number CDS983257I ; 24) ARTHROSCOPY CDS , Pack Number CDS983299G ; 25) ARTHROSCOPY CDS , Pack Number CDS983414C ; 26) ARTHROSCOPY SHOULDER, Pack Number CDS983462I ; 27) ARTHROSCOPY CDS SC-LF , Pack Number CDS983740G ; 28) SHOULDER ARTHROTOMY CDS SC-LF , Pack Number CDS983744F ; 29) ARTHROSCOPY CDS , Pack Number CDS983918F ; 30) KNEE ARTHROSCOPY CDS, Pack Number CDS984220I ; 31) ARTHROSCOPY CDS-LF, Pack Number CDS984426G ; 32) ARTHROSCOPY CDS-LF, Pack Number CDS984455C ; 33) ARTHROSCOPY CDS , Pack Number CDS984609B ; 34) ARTHROSCOPY CDS , Pack Number CDS984636A ; 35) ARTHROSCOPY CDS , Pack Number CDS985095D ; 36) ARTHROSCOPY CDS , Pack Number CDS985208B ; 37) ARTHROSCOPY CDS-LF, Pack Number CDS985294A ; 38) ARTHROSCOPY KNEE, Pack Number CDS985508D ; 39) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 40) ARTHROGRAM TRAY , Pack Number DYNDH1134…
description: FDA recall Z-3054-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack Number CDS940242I ; 3) ARTHROSCOPY-LF, Pack Number CDS940859J ; 4) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS940869U ; 5) ARTHROSCOPY CDS , Pack Number CDS940960I ; 6) ARTHROSCOPY CDS , Pack Number CDS941059L ; 7) ARTHROSCOPY CDS , Pack Number CDS941062K ; 8) ARTHROSCOPY CDS , Pack Number CDS941110L ; 9) ARTHROSCOPY , Pack Number CDS980751I ; 10) ARTHROSCOPY CDS , Pack Number CDS980893; 11) SHOULDER ARTHROSCOPY CDS-LF , Pack Number CDS981003K ; 12) ARTHROSCOPY CDS , Pack Number CDS981011B ; 13) ARTHROSCOPY PROCEDURE , Pack Number CDS981660J ; 14) SHOULDER ARTHROSCOPY CDS, Pack Number CDS982199G ; 15) ARTHROSCOPY CDS , Pack Number CDS982216C ; 16) ARTHROSCOPY CDS-LF, Pack Number CDS982232F ; 17) ARMC ARTHROSCOPY CDS, Pack Number CDS982278K ; 18) ASC SHOULDER ARTHRO CDS SRM-LF, Pack Number CDS982536C ; 19) ARTHROSCOPY PACK, Pack Number CDS982560D ; 20) ARTHROSCOPY CDS , Pack Number CDS982645J ; 21) ARTHROSCOPY CDS-LF, Pack Number CDS982757D ; 22) ARTHROSCOPY CDS , Pack Number CDS983102F ; 23) ARTHROSCOPY CDS-LF, Pack Number CDS983257I ; 24) ARTHROSCOPY CDS , Pack Number CDS983299G ; 25) ARTHROSCOPY CDS , Pack Number CDS983414C ; 26) ARTHROSCOPY SHOULDER, Pack Number CDS983462I ; 27) ARTHROSCOPY CDS SC-LF , Pack Number CDS983740G ; 28) SHOULDER ARTHROTOMY CDS SC-LF , Pack Number CDS983744F ; 29) ARTHROSCOPY CDS , Pack Number CDS983918F ; 30) KNEE ARTHROSCOPY CDS, Pack Number CDS984220I ; 31) ARTHROSCOPY CDS-LF, Pack Number CDS984426G ; 32) ARTHROSCOPY CDS-LF, Pack Number CDS984455C ; 33) ARTHROSCOPY CDS , Pack Number CDS984609B ; 34) ARTHROSCOPY CDS , Pack Number CDS984636A ; 35) ARTHROSCOPY CDS , Pack Number CDS985095D ; 36) ARTHROSCOPY CDS , Pack Number CDS985208B ; 37) ARTHROSCOPY CDS-LF, Pack Number CDS985294A ; 38) ARTHROSCOPY KNEE, Pack Number CDS985508D ; 39) BIOPSY/ARTHROGRA…
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: MedicalDevice
  name: Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack Number CDS940242I ; 3) ARTHROSCOPY-LF, Pack Number CDS940859J ; 4) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS940869U ; 5) ARTHROSCOPY CDS , Pack Number CDS940960I ; 6) ARTHROSCOPY CDS , Pack Number CDS941059L ; 7) ARTHROSCOPY CDS , Pack Number CDS941062K ; 8) ARTHROSCOPY CDS , Pack Number CDS941110L ; 9) ARTHROSCOPY , Pack Number CDS980751I ; 10) ARTHROSCOPY CDS , Pack Number CDS980893; 11) SHOULDER ARTHROSCOPY CDS-LF , Pack Number CDS981003K ; 12) ARTHROSCOPY CDS , Pack Number CDS981011B ; 13) ARTHROSCOPY PROCEDURE , Pack Number CDS981660J ; 14) SHOULDER ARTHROSCOPY CDS, Pack Number CDS982199G ; 15) ARTHROSCOPY CDS , Pack Number CDS982216C ; 16) ARTHROSCOPY CDS-LF, Pack Number CDS982232F ; 17) ARMC ARTHROSCOPY CDS, Pack Number CDS982278K ; 18) ASC SHOULDER ARTHRO CDS SRM-LF, Pack Number CDS982536C ; 19) ARTHROSCOPY PACK, Pack Number CDS982560D ; 20) ARTHROSCOPY CDS , Pack Number CDS982645J ; 21) ARTHROSCOPY CDS-LF, Pack Number CDS982757D ; 22) ARTHROSCOPY CDS , Pack Number CDS983102F ; 23) ARTHROSCOPY CDS-LF, Pack Number CDS983257I ; 24) ARTHROSCOPY CDS , Pack Number CDS983299G ; 25) ARTHROSCOPY CDS , Pack Number CDS983414C ; 26) ARTHROSCOPY SHOULDER, Pack Number CDS983462I ; 27) ARTHROSCOPY CDS SC-LF , Pack Number CDS983740G ; 28) SHOULDER ARTHROTOMY CDS SC-LF , Pack Number CDS983744F ; 29) ARTHROSCOPY CDS , Pack Number CDS983918F ; 30) KNEE ARTHROSCOPY CDS, Pack Number CDS984220I ; 31) ARTHROSCOPY CDS-LF, Pack Number CDS984426G ; 32) ARTHROSCOPY CDS-LF, Pack Number CDS984455C ; 33) ARTHROSCOPY CDS , Pack Number CDS984609B ; 34) ARTHROSCOPY CDS , Pack Number CDS984636A ; 35) ARTHROSCOPY CDS , Pack Number CDS985095D ; 36) ARTHROSCOPY CDS , Pack Number CDS985208B ; 37) ARTHROSCOPY CDS-LF, Pack Number CDS985294A ; 38) ARTHROSCOPY KNEE, Pack Number CDS985508D ; 39) BIOPSY/ARTHROGRAM TRAY, Pack Number DYNDH1115; 40) ARTHROGRAM TRAY , Pack Number DYNDH1134…
  manufacturer: MEDLINE INDUSTRIES, LP - Northfield
claims: enforcement-record
claims: FDA classified recall Z-3054-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-3054-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-3054-2024
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: MEDLINE INDUSTRIES, LP - Northfield
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: 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.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-04-08
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 00-399027M , Lot Number 19GLA310 ; 00-399027M , Lot Number 19KLA520 ; 00-399027M , Lot Number 19LLA487 ; 00-399027M , Lot Number 20LLA663 ; 00-399027M , Lot Number 21JLA024 ; 00-399027M , Lot Number 21KLA330 ; 00-399027M , Lot Number 22GLA379 ; 00-399027M , Lot Number 22HLA991 ; 00-399027M , Lot Number 23FLA497 ; 00-399027M , Lot Number 23GLA579 ; CDS940242I , Lot Number 19BBK957 ; CDS940242I , Lot Number 19KBO521 ; CDS940242I , Lot Number 20ABP687 ; CDS940242I , Lot Number 20BBW841 ; CDS940242I , Lot Number 20EBC100 ; CDS940242I , Lot Number 20EBD870 ; CDS940242I , Lot Number 20EBI718 ; CDS940242I , Lot Number 21BBM845 ; CDS940242I , Lot Number 21DBU612 ; CDS940859J , Lot Number 19BBN781 ; CDS940859J , Lot Number 19CBI613 ; CDS940859J , Lot Number 19DBF963 ; CDS940859J , Lot Number 19FBF630 ; CDS940859J , Lot Number 19FBZ846 ; CDS940859J , Lot Number 19KBX776 ; CDS940859J , Lot Number 20ABJ911 ; CDS940859J , Lot Number 20ABX308 ; CDS940859J , Lot Number 20DBB231 ; CDS940869U , Lot Number 22JBA443 ; CDS940869U , Lot Number 22JBR468 ; CDS940869U , Lot Number 22KBM258 ; CDS940869U , Lot Number 23ABM583 ; CDS940869U , Lot Number 23EBO018 ; CDS940869U , Lot Number 23FBQ994 ; CDS940869U , Lot Number 23IBJ529 ; CDS940869U , Lot Number 23IBQ730 ; CDS940869U , Lot Number 23JBT822 ; CDS940869U , Lot Number 24ABP580 ; CDS940960I , Lot Number 19ABS109 ; CDS940960I , Lot Number 19CBJ215 ; CDS940960I , Lot Number 19DBT115 ; CDS940960I , Lot Number 19EBZ737 ; CDS940960I , Lot Number 19GBF742 ; CDS940960I , Lot Number 19IBA018 ; CDS940960I , Lot Number 19KBC364 ; CDS940960I , Lot Number 19LBW494 ; CDS940960I , Lot Number 20CBG534 ; CDS940960I , Lot Number 20FBI380 ; CDS941059L , Lot Number 19ABX775 ; CDS941059L , Lot Number 19CBL345 ; CDS941059L , Lot Number 19EBK936 ; CDS941059L , Lot Number 19HBJ184 ; CDS941059L , Lot Number 19TBD995 ; CDS941059L , Lot Number 19JBR652 ; CDS941059L , Lot Number 19KBB784 ; CDS941062K , Lot Number 22AMA714 ; CDS941062K , Lot Number 22GMD219 ; CDS94…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide distribution.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-3054-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack Number CDS940242I ; 3) ARTHROSCOPY-LF, Pack Number CDS940859J ; 4) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS940869U ; 5) ARTHROSCOPY CDS , Pack Number CDS940960I ; 6) ARTHROSCOPY CDS , Pack Number CDS941059L ; 7) ARTHROSCOPY CDS , Pack Number CDS941062K ; 8) ARTHROSCOPY CDS , Pack Number CDS941110L ; 9) ARTHROSCOPY , Pack Number CDS980751I ; 10) ARTHROSCOPY CDS , Pack Number CDS980893; 11) SHOULDER ARTHROSCOPY CDS-LF , Pack Number CDS981003K ; 12) ARTHROSCOPY CDS , Pack Number CDS981011B ; 13) ARTHROSCOPY PROCEDURE , Pack Number CDS981660J ; 14) SHOULDER ARTHROSCOPY CDS, Pack Number CDS982199G ; 15) ARTHROSCOPY CDS , Pack Number CDS982216C ; 16) ARTHROSCOPY CDS-LF, Pack Number CDS982232F ; 17) ARMC ARTHROSCOPY CDS, Pack Number CDS982278K ; 18) ASC SHOULDER ARTHRO CDS SRM-LF, Pack Number CDS982536C ; 19) ARTHROSCOPY PACK, Pack Number CDS982560D ; 20) ARTHROSCOPY CDS , Pack Number CDS982645J ; 21) ARTHROSCOPY CDS-LF, Pack Number CDS982757D ; 22) ARTHROSCOPY CDS , Pack Number CDS983102F ; 23) ARTHROSCOPY CDS-LF, Pack Number CDS983257I ; 24) ARTHROSCOPY CDS , Pack Number CDS983299G ; 25) ARTHROSCOPY CDS , Pack Number CDS983414C ; 26) ARTHROSCOPY SHOULDER, Pack Number CDS983462I ; 27) ARTHROSCOPY CDS SC-LF , Pack Number CDS983740G ; 28) SHOULDER ARTHROTOMY CDS SC-LF , Pack Number CDS983744F ; 29) ARTHROSCOPY CDS , Pack Number CDS983918F ; 30) KNEE ARTHROSCOPY CDS, Pack Number CDS984220I ; 31) ARTHROSCOPY CDS-LF, Pack Number CDS984426G ; 32) ARTHROSCOPY CDS-LF, Pack Number CDS984455C ; 33) ARTHROSCOPY CDS , Pack Number CDS984609B ; 34) ARTHROSCOPY CDS , Pack Number CDS984636A ; 35) ARTHROSCOPY CDS , Pack Number CDS985095D ; 36) ARTHROSCOPY CDS , Pack Number CDS985208B ; 37) ARTHROSCOPY CDS-LF, Pack Number CDS985294A ; 38) ARTHROSCOPY KNEE, Pack Number CDS985508D ; 39) BIOPSY/ARTHROGRAM…
text: The FDA logged enforcement record Z-3054-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack Number CDS940242I ; 3) ARTHROSCOPY-LF, Pack Number CDS940859J ; 4) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS940869U ; 5) ARTHROSCOPY CDS , Pack Number CDS940960I ; 6) ARTHROSCOPY CDS , Pack Number CDS941059L ; 7) ARTHROSCOPY CDS , Pack Number CDS941062K ; 8) ARTHROSCOPY CDS , Pack Number CDS941110L ; 9) ARTHROSCOPY , Pack Number CDS980751I ; 10) ARTHROSCOPY CDS , Pack Number CDS980893; 11) SHOULDER ARTHROSCOPY CDS-LF , Pack Number CDS981003K ; 12) ARTHROSCOPY CDS , Pack Number CDS981011B ; 13) ARTHROSCOPY PROCEDURE , Pack Number CDS981660J ; 14) SHOULDER ARTHROSCOPY CDS, Pack Number CDS982199G ; 15) ARTHROSCOPY CDS , Pack Number CDS982216C ; 16) ARTHROSCOPY CDS-LF, Pack Number CDS982232F ; 17) ARMC ARTHROSCOPY CDS, Pack Number CDS982278K ; 18) ASC SHOULDER ARTHRO CDS SRM-LF, Pack Number CDS982536C ; 19) ARTHROSCOPY PACK, Pack Number CDS982560D ; 20) ARTHROSCOPY CDS , Pack Number CDS982645J ; 21) ARTHROSCOPY CDS-LF, Pack Number CDS982757D ; 22) ARTHROSCOPY CDS , Pack Number CDS983102F ; 23) ARTHROSCOPY CDS-LF, Pack Number CDS983257I ; 24) ARTHROSCOPY CDS , Pack Number CDS983299G ; 25) ARTHROSCOPY CDS , Pack Number CDS983414C ; 26) ARTHROSCOPY SHOULDER, Pack Number CDS983462I ; 27) ARTHROSCOPY CDS SC-LF , Pack Number CDS983740G ; 28) SHOULDER ARTHROTOMY CDS SC-LF , Pack Number CDS983744F ; 29) ARTHROSCOPY CDS , Pack Number CDS983918F ; 30) KNEE ARTHROSCOPY CDS, Pack Number CDS984220I ; 31) ARTHROSCOPY CDS-LF, Pack Number CDS984426G ; 32) ARTHROSCOPY CDS-LF, Pack Number CDS984455C ; 33) ARTHROSCOPY CDS , Pack Number CDS984609B ; 34) ARTHROSCOPY CDS , Pack Number CDS984636A ; 35) ARTHROSCOPY CDS , Pack Number CDS985095D ; 36) ARTHROSCOPY CDS , Pack Number CDS985208B ; 37) ARTHROSCOPY CDS-LF, Pack Number CDS985294A ; 38) ARTHROSCOPY KNEE, Pack Number…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-3054-2024 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.