C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
type: Dataset
description: FDA recall Z-2639-2024 — Microtek Medical Inc. is recalling C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs). (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
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: C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
  type: MedicalDevice
  manufacturer: Microtek Medical Inc.
claims: FDA recall Z-2639-2024: Microtek Medical Inc. is recalling C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
claims: FDA classified recall Z-2639-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2639-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2639-2024
      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: Microtek Medical Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-06-03
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: SKU/UDI-Device Identifier: 2000S/00748426002085; Lot Numbers: 190220,200424,200424,191214,191025,191118,211024,210602,211016,211016,210912,211024,210912,210912,210912,210727,210828,210608,210608,210411,210411,210323,210118,210113,210113,201123,201009,200423,190429,200619,190719,191025,190614,190715,190614,200424,190614,200619,200914,191225,191027,191106,181005,190715,181123,190429,190606,181207,190220,190805,190503,190304,200331,181207,200914,200914,190606,191209,190719,191225,200424,190606,190715,191027,190429,181005,181207,190606,181123,200311,200311,191118,190826,211116,211116,211116,211116,211024,211024,210714,210714,211116,211024,211024,211116,211016,211016,211016,211016,210912,210912,210827,210827,210912,210912,210828,210828,210828,210828,210827,210608,210608,210608,210608,210602,210504,210411,210411,210411,210323,210323,210323,210323,210113,201123,201123,201009,200903,200914,201009,200903,200903,200903,200903,201009,200619,191106,190304,200914,181207,191210,190614,190220,190715,191225,181005,190614,181005,200914,200619,190719,200423,191106,190220,190429,190826,200619,191118,181005,191225,190614,190429,181207,181005,191118,190429,190220,191027,190715,181123,190110,200903,191209,200423,190805,231120,231011,231011,231104,231104,231009,230919,230919,230919,230919,230824,230825,230824,230824,230824,230615,230622,230615,230622,230622,230615,230614,230614,230614,230614,230614,230425,230425,230425,230425,230327,230327,230327,230327,230130,230130,221125,221125,221125,221126,221126,221124,221124,221123,221124,221123,221121,221121,221123,221012,221012,221012,221012,220927,220913,220930,220112,220425,220425,220316,220316,220107,220112,220107,191209,191209,211116,211116,211024,211116,210828,211024,211024,211024,211116,211024,211116,211024,211116,211024,211016,210912,210714,210827,210912,210912,210727,210828,210323,210323,210323,210118,210118,210118,210113,210112,201009,191210,231011,231104,231104,231011,230919,230825,230824,230615,230425,230425,230425,230327,230327,230130…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.
      status: recorded

FDA recall Z-2639-2024: Microtek Medical Inc. is recalling C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
type: Claim
text: The FDA logged enforcement record Z-2639-2024: Microtek Medical Inc. is voluntarily recalling C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs). — reason: During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-06-03. Affected lots/codes: SKU/UDI-Device Identifier: 2000S/00748426002085; Lot Numbers: 190220,200424,200424,191214,191025,191118,211024,210602,211016,211016,210912,211024,210912,210912,210912,210727,210828,210608,210608,210411,210411,210323,210118,210113,210113,201123,201009,200423,190429,200619,190719,191025,190614,190715,190614,200424,190614,200619,200914,191225,191027,191106,181005,190715,181123,190429,190606,181207,190220,190805,190503,190304,200331,181207,200914,200914,190606,191209,190719,191225,200424,190606,190715,191027,190429,181005,181207,190606,181123,200311,200311,191118,190826,211116,211116,211116,211116,211024,211024,210714,210714,211116,211024,211024,211116,211016,211016,211016,211016,210912,210912,210827,210827,210912,210912,210828,210828,210828,210828,210827,210608,210608,210608,210608,210602,210504,210411,210411,210411,210323,210323,210323,210323,210113,201123,201123,201009,200903,200914,201009,200903,200903,200903,200903,201009,200619,191106,190304,200914,181207,191210,190614,190220,190715,191225,181005,190614,181005,200914,200619,190719,200423,191106,190220,190429,190826,200619,191118,181005,191225,190614,190429,181207,181005,191118,190429,190220,191027,190715,181123,190110,200903,191209,200423,190805,231120,231011,231011,231104,231104,231009,230919,230919,230919,230919,230824,230825,230824,230824,230824,230615,230622,230615,230622,230622,230615,230614,230614,230614,230614,230614,230425,230425,230425,230425,230327,230327,230327,230327,230130,230130,221125,221125,221125,221126,221126…
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-2639-2024 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.