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  "name": "ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product  Code 68-2230-28",
  "description": "FDA recall Z-0017-2025 — Smiths Medical ASD Inc. is recalling ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product  Code 68-2230-28 (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": "ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product  Code 68-2230-28",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0017-2025/enforcement-record",
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      "name": "FDA recall Z-0017-2025: Smiths Medical ASD Inc. is recalling ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product  Code 68-2230-28",
      "text": "The FDA logged enforcement record Z-0017-2025: Smiths Medical ASD Inc. is voluntarily recalling ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product  Code 68-2230-28 — reason: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-06-26. Affected lots/codes: UDI/DI 30610586044179, Lot Numbers:  4010559AB, 4010560AB, 4010563AB, 4010573AB, 4016496AB, 4010561AB, 4010562AB, 4016490AB, 4010570AB, 4010569AB, 4016494AB, 4016497AB, 4010571AB, 4016491AB, 4010572AB, 4010574AB, 4016493AB, 4022630AB, 4025275AB, 4016492AB, 4016495AB, 4022621AB, 4022625AB, 4022628AB, 4006931AB, 4006933AB, 4006930AB, 4006932AB, 4022622AB, 4022623AB, 4022627AB, 4022624AB, 4022626AB, 4022632AB, 4022629AB, 4022631AB, 4025277AB, 4022633AB, 4022634AB, 4025274AB, 4022635AB, 4033938AB, 4033939AB, 4025281AB, 4033937AB, 4025278AB, 4025279AB, 4025280AB, 4033943AB, 4025288AB, 4025282AB, 4025289AB, 4025285AB, 4025286AB, 4025290AB, 4025287AB, 4033934AB, 4033928AB, 4030519AB, 4025291AB, 4025292AB, 4025293AB, 4039970AB, 4039972AB, 4030518AB, 4025295AB, 4039971AB, 4033942AB, 4033927AB, 4033940AB, 4033931AB, 4033930AB, 4033932AB, 4010548AB, 4010551AB, 4033933AB, 4033935AB, 4033936AB, 4039983AB, 4033941AB, 4039973AB, 4039969AB, 4039974AB, 4039987AB, 4039978AB, 4039981AB, 4039975AB, 4039976AB, 4039977AB, 4039979AB, 4039985AB, 4039992AB, 4039988AB, 4039980AB, 4039984AB, 4046424AB, 4039982AB, 4039991AB, 4046419AB, 4039986AB, 4039990AB, 4046422AB, 4039989AB, 4046421AB, 4046423AB, 4046420AB, 4046425AB, 4046430AB, 4046427AB, 4046428AB, 4046426AB, 4046429AB, 4046436AB, 4046431AB, 4058051AB, 4046432AB, 4046437AB, 4046435AB, 4046434AB, 4046433AB, 4046438AB, 4068090, 4071901AB, 4068091, 4068095, 4058044AB, 4058046AB, 4058045AB, 4058047AB, 4058048AB, 4058049AB, 4058050AB, 4058054AB, 4058057AB, 4058062AB, 4058052AB, 4058056AB, 4058063AB, 4058068AB, 4058064AB, 4071892AB, 4071893AB, 4069071AB, 4058066AB, 4071891AB, 4174007AB, 4124420AB, 4146001AB, 4124419AB, 4146000AB, 4147144, 4084056, 4058069AB, 4080944AB, 4058072AB, 4084055, 4058070AB, 4080951AB, 4067648-ENG, 4124438AB, 4124432AB, 4124437AB, 4124439AB, 4146564, 4147141AB, 4174026AB, 4145999AB, 4146002AB, 4147145, 4147143, 4146566, 4146565, 4146567, 4157653AB, 4157654AB, 4158821AB, 4172034, 4163678AB, 4163679AB, 4158820AB, 4163675AB, 4172026AB, 4174012AB, 4174011AB, 4163680AB, 4174016AB, 4174014AB, 4174013AB, 4174643AB, 4174642AB, 4174644AB, 4174641AB, 4174645AB, 4183673AB, 4174646AB, 4174647AB, 4183669AB, 4183007, 4183010, 4183670AB, 4183671AB, 4183672AB, 4183674AB. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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      "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."
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      "name": "FDA classified recall Z-0017-2025 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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      "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."
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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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            "Value": "Ongoing — the recall is still being carried out.",
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            "Field": "Recalling firm",
            "Value": "Smiths Medical ASD Inc.",
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            "Value": "Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.",
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