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  "name": "LifeShield Drug Library Management (DLM);  LifeShield Infusion Safety Software Suite v2.2    List Number 17003-02",
  "description": "FDA recall Z-0965-2026 — ICU Medical, Inc. is recalling LifeShield Drug Library Management (DLM);  LifeShield Infusion Safety Software Suite v2.2    List Number 17003-02 (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.",
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      "name": "FDA recall Z-0965-2026: ICU Medical, Inc. is recalling LifeShield Drug Library Management (DLM);  LifeShield Infusion Safety Software Suite v2.2    List Number 17003-02",
      "text": "The FDA logged enforcement record Z-0965-2026: ICU Medical, Inc. is voluntarily recalling LifeShield Drug Library Management (DLM);  LifeShield Infusion Safety Software Suite v2.2    List Number 17003-02 — reason: For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-11-24. Affected lots/codes: version 2.2.1  UDI-DI 00887709127227   Issue affects customers who migrated from LifeShield DLM v2.1x to LifeShield DLM v2.2.1 and have any version of a Plum Duo v1.1 drug library that was approved or locked for review before the migration.. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0965-2026 as Class II",
      "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.",
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      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "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.",
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      "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."
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