FDA recall Z-2626-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling See RES description (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.
openFDA drug & device enforcement (recall) reports
FDA recall Z-2626-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling See RES description
The FDA logged enforcement record Z-2626-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling See RES description — reason: 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: Ongoing — the recall is still being carried out.. Initiated 2024-04-08. Affected lots/codes: CDS981579O , Lot Number 21JBM647 ; CDS981579O , Lot Number 21JBQ860 ; CDS981579O , Lot Number 22CBX741 ; CDS981579O , Lot Number 19EBL586 ; CDS981579O , Lot Number 19GBJ538 ; CDS981579O , Lot Number 19IBH976 ; CDS981579O , Lot Number 19JBZ536 ; CDS981579O , Lot Number 19KBB918 ; CDS981579O , Lot Number 20ABP061 ; CDS981579O , Lot Number 20BBA647 ; CDS981579O , Lot Number 20DBM006 ; CDS981579O , Lot Number 20FBS525 ; CDS981579O , Lot Number 21ABO831 ; CDS981579O , Lot Number 21BBI363 ; CDS981579O , Lot Number 21CBI409 ; CDS981579O , Lot Number 21DBG604 ; CDS981579O , Lot Number 21FBC673 ; DYNDA2391, Lot Number 21JBR496 ; DYNDA2508, Lot Number 19FBY839 ; DYNJ0117039, Lot Number 19ALA192 ; DYNJ0117039, Lot Number 19FLA299 ; DYNJ0117039, Lot Number 19LLA121 ; DYNJ0117039, Lot Number 20ALA869 ; DYNJ0117039, Lot Number 20CLA195 ; DYNJ0117039, Lot Number 20GLA412 ; DYNJ0117039, Lot Number 20ILA113 ; DYNJ0117039, Lot Number 20JLA806 ; DYNJ0117039, Lot Number 20KLA286 ; DYNJ0117039, Lot Number 21ALA145 ; 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A RECORDED FDA enforcement action (occurred=true).
openFDA drug & device enforcement (recall) reports — U.S. FDA
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RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.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-2626-2024 as Class II
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.
U.S. FDA recall classification (openFDA enforcement)
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.
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.
Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
a recorded enforcement action, not proof of harm or causation; not medical advice
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.
Ongoing — the recall is still being carried out.
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.
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