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    "name": "Salem Sump PVC Tubes:    Product Code/Product Name:  1180264408\tSalem Sump\" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm  1180264416\tSalem Sump\" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm  1180264424\tSalem Sump\" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm  1180264432\tSalem Sump\" PVC Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm  1180264440\tSalem Sump\" PVC Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm  1180264457\tSalem Sump\" PVC Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm  1180264523\tSalem Sump\" Polyurethane Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm  1180264531\tSalem Sump\" Polyurethane Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm  1180264549\tSalem Sump\" Polyurethane Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm  1180264556\tSalem Sump\" Polyurethane Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm  1180264895\tSalem Sump PVC Gastroduodenal Tube, 20 Fr/Ch (3.3mm), 108 cm  8888264804\tSalem Sump PVC Gastroduodenal Tube, 10Fr/Ch (3.3 mm) x 85 cm  8888264820\tSalem Sump PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 108 cm  8888264846\tSalem Sump PVC Gastroduodenal Tube, 14 Fr/Ch (4.7mm), 108 cm  8888264861\tSalem Sump PVC Gastroduodenal Tube, 16 Fr/Ch (5.3mm), 108 cm  8888264887\tSalem Sump PVC Gastroduodenal Tube, 18 Fr/Ch (6.0mm), 108 cm    SKUs not distributed in US",
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      "name": "FDA recall Z-0211-2026: Cardinal Health 200, LLC is recalling Salem Sump PVC Tubes:    Product Code/Product Name:  1180264408\tSalem Sump\" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm  1180264416\tSalem Sump\" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm  1180264424\tSalem Sump\" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm  1180264432\tSalem Sump\" PVC Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm  1180264440\tSalem Sump\" PVC Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm  1180264457\tSalem Sump\" PVC Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm  1180264523\tSalem Sump\" Polyurethane Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm  1180264531\tSalem Sump\" Polyurethane Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm  1180264549\tSalem Sump\" Polyurethane Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm  1180264556\tSalem Sump\" Polyurethane Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm  1180264895\tSalem Sump PVC Gastroduodenal Tube, 20 Fr/Ch (3.3mm), 108 cm  8888264804\tSalem Sump PVC Gastroduodenal Tube, 10Fr/Ch (3.3 mm) x 85 cm  8888264820\tSalem Sump PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 108 cm  8888264846\tSalem Sump PVC Gastroduodenal Tube, 14 Fr/Ch (4.7mm), 108 cm  8888264861\tSalem Sump PVC Gastroduodenal Tube, 16 Fr/Ch (5.3mm), 108 cm  8888264887\tSalem Sump PVC Gastroduodenal Tube, 18 Fr/Ch (6.0mm), 108 cm    SKUs not distributed in US",
      "text": "The FDA logged enforcement record Z-0211-2026: Cardinal Health 200, LLC is voluntarily recalling Salem Sump PVC Tubes:    Product Code/Product Name:  1180264408\tSalem Sump\" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm  1180264416\tSalem Sump\" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm  1180264424\tSalem Sump\" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm  1180264432\tSalem Sump\" PVC Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm  1180264440\tSalem Sump\" PVC Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm  1180264457\tSalem Sump\" PVC Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm  1180264523\tSalem Sump\" Polyurethane Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm  1180264531\tSalem Sump\" Polyurethane Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm  1180264549\tSalem Sump\" Polyurethane Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm  1180264556\tSalem Sump\" Polyurethane Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm  1180264895\tSalem Sump PVC Gastroduodenal Tube, 20 Fr/Ch (3.3mm), 108 cm  8888264804\tSalem Sump PVC Gastroduodenal Tube, 10Fr/Ch (3.3 mm) x 85 cm  8888264820\tSalem Sump PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 108 cm  8888264846\tSalem Sump PVC Gastroduodenal Tube, 14 Fr/Ch (4.7mm), 108 cm  8888264861\tSalem Sump PVC Gastroduodenal Tube, 16 Fr/Ch (5.3mm), 108 cm  8888264887\tSalem Sump PVC Gastroduodenal Tube, 18 Fr/Ch (6.0mm), 108 cm    SKUs not distributed in US — reason: Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-18. Affected lots/codes: Product Code/Product Name/UDI-DI:  1180264408 Salem Sump\" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 10192253006940 1180264416 Salem Sump\" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 10192253006957 1180264424 Salem Sump\" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 10192253006964 1180264432 Salem Sump\" PVC Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 10192253006971 1180264440 Salem Sump\" PVC Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 10192253007053 1180264457 Salem Sump\" PVC Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 10192253006568 1180264523 Salem Sump\" Polyurethane Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 10192253007060 1180264531 Salem Sump\" Polyurethane Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 10192253006988 1180264549 Salem Sump\" Polyurethane Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 10192253006995 1180264556 Salem Sump\" Polyurethane Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 10192253007008 1180264895 Salem Sump PVC Gastroduodenal Tube, 20 Fr/Ch (3.3mm), 108 cm 10192253007015 8888264804 Salem Sump PVC Gastroduodenal Tube, 10Fr/Ch (3.3 mm) x 85 cm 10192253012408 8888264820 Salem Sump PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 108 cm 10192253012415 8888264846 Salem Sump PVC Gastroduodenal Tube, 14 Fr/Ch (4.7mm), 108 cm 10192253012422 8888264861 Salem Sump PVC Gastroduodenal Tube, 16 Fr/Ch (5.3mm), 108 cm 10192253012439 8888264887 Salem Sump PVC Gastroduodenal Tube, 18 Fr/Ch (6.0mm), 108 cm 10192253012446  All Lots. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-0211-2026 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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      "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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      "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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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
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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": "Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.",
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            "Value": "Product Code/Product Name/UDI-DI:  1180264408 Salem Sump\" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 10192253006940 1180264416 Salem Sump\" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 10192253006957 1180264424 Salem Sump\" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 10192253006964 1180264432 Salem Sump\" PVC Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 10192253006971 1180264440 Salem Sump\" PVC Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 10192253007053 1180264457 Salem Sump\" PVC Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 10192253006568 1180264523 Salem Sump\" Polyurethane Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm 10192253007060 1180264531 Salem Sump\" Polyurethane Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm 10192253006988 1180264549 Salem Sump\" Polyurethane Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm 10192253006995 1180264556 Salem Sump\" Polyurethane Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm 10192253007008 1180264895 Salem Sump PVC Gastroduodenal Tube, 20 Fr/Ch (3.3mm), 108 cm 10192253007015 8888264804 Salem Sump PVC Gastroduodenal Tube, 10Fr/Ch (3.3 mm) x 85 cm 10192253012408 8888264820 Salem Sump PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 108 cm 10192253012415 8888264846 Salem Sump PVC Gastroduodenal Tube, 14 Fr/Ch (4.7mm), 108 cm 10192253012422 8888264861 Salem Sump PVC Gastroduodenal Tube, 16 Fr/Ch (5.3mm), 108 cm 10192253012439 8888264887 Salem Sump PVC Gastroduodenal Tube, 18 Fr/Ch (6.0mm), 108 cm 10192253012446  All Lots",
            "Status": "recorded"
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            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.",
            "Status": "recorded"
          }
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