{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1367-2026.jsonld", "@type": "schema:Dataset", "name": "Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060", "description": "FDA recall Z-1367-2026 — Bard Peripheral Vascular Inc is recalling Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060 (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/", "isAccessibleForFree": true, "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native", "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object", "dateModified": "2026-06-24T07:02:03.626072+00:00", "isBasedOn": { "@type": "schema:Dataset", "name": "openFDA drug & device enforcement (recall) reports", "url": "https://open.fda.gov/apis/drug/enforcement/", "creator": { "@type": "schema:GovernmentOrganization", "name": "U.S. Food & Drug Administration" } }, "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1367-2026&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060", "manufacturer": { "@type": "schema:Organization", "name": "Bard Peripheral Vascular Inc" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1367-2026/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1367-2026: Bard Peripheral Vascular Inc is recalling Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060", "text": "The FDA logged enforcement record Z-1367-2026: Bard Peripheral Vascular Inc is voluntarily recalling Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060 — reason: Due to damage to outer tray that can potentially compromise the sterile barrier. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-12. Affected lots/codes: Product Name: Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600060 UDI code: (01)00801741051692(17)300728(10)HUKV0547 Lot Number: HUKV0547 Product Name: Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600100 UDI code: (01)00801741051708(17)300628(10)HUKU0307 (01)00801741051708(17)300828(10)HUKW1312 Lot Number: HUKU0307 HUKW1312 Product Name: Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray (Short External Length) with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600120 UDI code: (01)00801741051715(17)300628(10)HUKU0274 Lot Number: HUKU0274 Product Name: Hickman 7 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600310 UDI code: (01)00801741051739(17)300428(10)HUKS0783 (01)00801741051739(17)300628(10)HUKU0250 (01)00801741051739(17)300628(10)HUKU0310 Lot Number: HUKS0783 HUKU0250 HUKU0310 Product Name: Hickman 12 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600350 UDI code: (01)00801741051777(17)300428(10)HUKR1359 (01)00801741051777(17)300428(10)HUKS0811 (01)00801741051777(17)300628(10)HUKU0316 Lot Number: HUKR1359 HUKS0811 HUKU0316 Product Name:Broviac 4.2 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600520 UDI code: (01)00801741051807(17)270528(10)HUKS1468 (01)00801741051807(17)270528(10)HUKU0246 (01)00801741051807(17)270528(10)HUKU0278 (01)00801741051807(17)270528(10)HUKU0289 (01)00801741051807(17)270528(10)HUKU0305 (01)00801741051807(17)270528(10)HUKU0327 (01)00801741051807(17)270528(10)HUKU0338 (01)00801741051807(17)270528(10)HUKU0353 (01)00801741051807(17)270528(10)HUKW0164 (01)00801741051807(17)280328(10)HUKW1278 (01)00801741051807(17)280328(10)HUKW1285 Lot Number: HUKS1468 HUKU0246 HUKU0278 HUKU0289 HUKU0305 HUKU0327 HUKU0338 HUKU0353 HUKW0164 HUKW1278 HUKW1285 Product Name:Broviac 6.6 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600540 UDI code: (01)00801741051821(17)290428(10)HUKR0064 (01)00801741051821(17)290628(10)HUKR0065 (01)00801741051821(17)290628(10)HUKR0067 (01)00801741051821(17)300128(10)HUKU0252 (01)00801741051821(17)300128(10)HUKU0270 (01)00801741051821(17)300128(10)HUKU0279 (01)00801741051821(17)300128(10)HUKU0308 (01)00801741051821(17)300128(10)HUKU0334 (01)00801741051821(17)300328(10)HUKV0359 (01)00801741051821(17)300328(10)HUKV0550 (01)00801741051821(17)300328(10)HUKV0560 (01)00801741051821(17)300328(10)HUKW0156 (01)00801741051821(17)300328(10)HUKW0159 Lot Number: HUKR0064 HUKR0065 HUKR0067 HUKU0252 HUKU0270 HUKU0279 HUKU0308 HUKU0334 HUKV0359 HUKV0550 HUKV0560 HUKW0156 HUKW0159 Product Name:Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600560 UDI code: (01)00801741051845(17)290828(10)HUKS0776 (01)00801741051845(17)290828(10)HUKS0816 (01)00801741051845(17)290928(10)HUKS1220 (01)00801741051845(17)290928(10)HUKU0302 (01)00801741051845(17)290928(10)HUKU0311 (01)00801741051845(17)300128(10)HUKU0345 (01)00801741051845(17)300128(10)HUKU0350 (01)00801741051845(17)300128(10)HUKV0376 (01)00801741051845(17)300128(10)HUKV0555 Lot Number: HUKS0776 HUKS0816 HUKS1220 HUKU0302 HUKU0311 HUKU0345 HUKU0350 HUKV0376 HUKV0555 Product Name:Hickman 7 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600570 UDI code: (01)00801741051869(17)290628(10)HUKR1342 (01)00801741051869(17)290628(10)HUKR1344 (01)00801741051869(17)300128(10)HUKR1346 (01)00801741051869(17)290628(10)HUKR1347 (01)00801741051869(17)300128(10)HUKR1348 (01)00801741051869(17)300128(10)HUKR1356 (01)00801741051869(17)290628(10)HUKR1363 (01)00801741051869(17)290628(10)HUKR1367 (01)00801741051869(17)300128(10)HUKR1368 (01)00801741051869(17)300128(10)HUKS0774 (01)00801741051869(17)300128(10)HUKU0238 (01)00801741051869(17)300128(10)HUKU0242 (01)00801741051869(17)300128(10)HUKU0247 (01)00801741051869(17)300128(10)HUKU0253 (01)00801741051869(17)300128(10)HUKU0254 (01)00801741051869(17)300128(10)HUKU0266 (01)00801741051869(17)300128(10)HUKU0280 (01)00801741051869(17)300128(10)HUKU0283 (01)00801741051869(17)300128(10)HUKU0284 (01)00801741051869(17)300128(10)HUKU0290 (01)00801741051869(17)300128(10)HUKU0293 (01)00801741051869(17)300128(10)HUKU0294 (01)00801741051869(17)300128(10)HUKU0298 (01)00801741051869(17)300128(10)HUKU0312 (01)00801741051869(17)300128(10)HUKU0339 (01)00801741051869(17)300328(10)HUKU0340 (01)00801741051869(17)300128(10)HUKU0344 (01)00801741051869(17)300128(10)HUKU0354 (01)00801741051869(17)300328(10)HUKV0549 (01)00801741051869(17)300328(10)HUKV0569 (01)00801741051869(17)300328(10)HUKV0576 (01)00801741051869(17)300328(10)HUKV0581 (01)00801741051869(17)300328(10)HUKW0148 Lot Number: HUKR1342 HUKR1344 HUKR1346 HUKR1347 HUKR1348 HUKR1356 HUKR1363 HUKR1367 HUKR1368 HUKS0774 HUKU0238 HUKU0242 HUKU0247 HUKU0253 HUKU0254 HUKU0266 HUKU0280 HUKU0283 HUKU0284 HUKU0290 HUKU0293 HUKU0294 HUKU0298 HUKU0312 HUKU0339 HUKU0340 HUKU0344 HUKU0354 HUKV0549 HUKV0569 HUKV0576 HUKV0581 HUKW0148 Product Name:Hickman 12 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600620 UDI code: (01)00801741051913(17)291028(10)HUJY0302 (01)00801741051913(17)291028(10)HUJY1095 (01)00801741051913(17)291128(10)HUJZ1332 (01)00801741051913(17)291128(10)HUJZ1336 (01)00801741051913(17)291128(10)HUJZ1339 (01)00801741051913(17)291128(10)HUJZ1340 (01)00801741051913(17)300328(10)HUKR1349 (01)00801741051913(17)300328(10)HUKR1364 (01)00801741051913(17)300428(10)HUKS0784 (01)00801741051913(17)300428(10)HUKS0806 (01)00801741051913(17)300428(10)HUKS1217 (01)00801741051913(17)230428(10)HUKS1218 (01)00801741051913(17)300628(10)HUKU0259 (01)00801741051913(17)300628(10)HUKU0351 (01)00801741051913(17)300728(10)HUKV0349 (01)00801741051913(17)300728(10)HUKV0567 (01)00801741051913(17)300828(10)HUKW0534 Lot Number: HUJY0302 HUJY1095 HUJZ1332 HUJZ1336 HUJZ1339 HUJZ1340 HUKR1349 HUKR1364 HUKS0784 HUKS0806 HUKS1217 HUKS1218 HUKU0259 HUKU0351 HUKV0349 HUKV0567 HUKW0534 Product Name:Hickman 12.5 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600650 UDI code: (01)00801741051975(17)300228(10)HUKQ0535 (01)00801741051975(17)300428(10)HUKS1474 (01)00801741051975(17)300428(10)HUKS1483 (01)00801741051975(17)300628(10)HUKU0313 (01)00801741051975(17)300628(10)HUKU0317 (01)00801741051975(17)300628(10)HUKU0328 (01)00801741051975(17)300728(10)HUKV0354 (01)00801741051975(17)300728(10)HUKV0371 (01)00801741051975(17)300828(10)HUKW0171 (01)00801741051975(17)300828(10)HUKW1283 Lot Number: HUKQ0535 HUKS1474 HUKS1483 HUKU0313 HUKU0317 HUKU0328 HUKV0354 HUKV0371 HUKW0171 HUKW1283 Product Name:Hickman 10 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 606560 UDI code: (01)00801741052019(17)290828(10)HUKR1370 (01)00801741052019(17)290928(10)HUKS1219 (01)00801741052019(17)300128(10)HUKU0255 (01)00801741052019(17)290928(10)HUKU0324 (01)00801741052019(17)300128(10)HUKV0578 (01)00801741052019(17)300128(10)HUKW0172 (01)00801741052019(17)300128(10)HUKW1315 Lot Number: HUKR1370 HUKS1219 HUKU0255 HUKU0324 HUKV0578 HUKW0172 HUKW1315 Product Name:Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600100CE UDI code: (01)00801741051708(17)300628(10)HUKU0307 (01)00801741051708(17)300828(10)HUKW1312 Lot Number: HUKU0307 HUKW1312 Product Name:Hickman 7 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600310CE UDI code: (01)00801741051739(17)300428(10)HUKS0783 (01)00801741051739(17)300628(10)HUKU0250 (01)00801741051739(17)300628(10)HUKU0310 Lot Number: HUKS0783 HUKU0250 HUKU0310 Product Name:Broviac 4.2 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600520CE UDI code: (01)00801741051807(17)270528(10)HUKS1468 (01)00801741051807(17)270528(10)HUKU0246 (01)00801741051807(17)270528(10)HUKU0278 (01)00801741051807(17)270528(10)HUKU0289 (01)00801741051807(17)270528(10)HUKU0305 (01)00801741051807(17)270528(10)HUKU0338 (01)00801741051807(17)270528(10)HUKU0353 (01)00801741051807(17)270528(10)HUKW0164 (01)00801741051807(17)280328(10)HUKW1278 (01)00801741051807(17)280328(10)HUKW1285 Lot Number: HUKS1468 HUKU0246 HUKU0278 HUKU0289 HUKU0305 HUKU0338 HUKU0353 HUKW0164 HUKW1278 HUKW1285 Product Name:Broviac 6.6 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600540CE UDI code: (01)00801741051821(17)290428(10)HUKR0064 (01)00801741051821(17)290628(10)HUKR0065 (01)00801741051821(17)290628(10)HUKR0067 (01)00801741051821(17)300128(10)HUKU0252 (01)00801741051821(17)300128(10)HUKU0270 (01)00801741051821(17)300128(10)HUKU0279 (01)00801741051821(17)300128(10)HUKU0308 (01)00801741051821(17)300128(10)HUKU0334 (01)00801741051821(17)300328(10)HUKV0359 (01)00801741051821(17)300328(10)HUKV0550 (01)00801741051821(17)300328(10)HUKW0156 (01)00801741051821(17)300328(10)HUKW0159 Lot Number: HUKR0064 HUKR0065 HUKR0067 HUKU0252 HUKU0270 HUKU0279 HUKU0308 HUKU0334 HUKV0359 HUKV0550 HUKW0156 HUKW0159 Product Name:Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600560CE UDI code: (01)00801741051845(17)290828(10)HUKS0776 (01)00801741051845(17)290828(10)HUKS0816 (01)00801741051845(17)290928(10)HUKS1220 (01)00801741051845(17)290928(10)HUKU0302 (01)00801741051845(17)290928(10)HUKU0311 (01)00801741051845(17)300128(10)HUKU0345 (01)00801741051845(17)300128(10)HUKU0350 (01)00801741051845(17)300128(10)HUKV0555 Lot Number: HUKS0776 HUKS0816 HUKS1220 HUKU0302 HUKU0311 HUKU0345 HUKU0350 HUKV0555 Product Name:Hickman 7 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600570CE UDI code: (01)00801741051869(17)290628(10)HUKR1342 (01)00801741051869(17)290628(10)HUKR1344 (01)00801741051869(17)300128(10)HUKR1346 (01)00801741051869(17)290628(10)HUKR1347 (01)00801741051869(17)300128(10)HUKR1348 (01)00801741051869(17)300128(10)HUKR1356 (01)00801741051869(17)290628(10)HUKR1363 (01)00801741051869(17)290628(10)HUKR1367 (01)00801741051869(17)300128(10)HUKR1368 (01)00801741051869(17)300128(10)HUKS0774 (01)00801741051869(17)300128(10)HUKU0238 (01)00801741051869(17)300128(10)HUKU0242 (01)00801741051869(17)300128(10)HUKU0247 (01)00801741051869(17)300128(10)HUKU0253 (01)00801741051869(17)300128(10)HUKU0254 (01)00801741051869(17)300128(10)HUKU0266 (01)00801741051869(17)300128(10)HUKU0280 (01)00801741051869(17)300128(10)HUKU0283 (01)00801741051869(17)300128(10)HUKU0284 (01)00801741051869(17)300128(10)HUKU0290 (01)00801741051869(17)300128(10)HUKU0293 (01)00801741051869(17)300128(10)HUKU0294 (01)00801741051869(17)300128(10)HUKU0298 (01)00801741051869(17)300128(10)HUKU0312 (01)00801741051869(17)300128(10)HUKU0339 (01)00801741051869(17)300328(10)HUKU0340 (01)00801741051869(17)300128(10)HUKU0344 (01)00801741051869(17)300128(10)HUKU0354 (01)00801741051869(17)300328(10)HUKV0549 (01)00801741051869(17)300328(10)HUKV0576 (01)00801741051869(17)300328(10)HUKW0148 Lot Number: HUKR1342 HUKR1344 HUKR1346 HUKR1347 HUKR1348 HUKR1356 HUKR1363 HUKR1367 HUKR1368 HUKS0774 HUKU0238 HUKU0242 HUKU0247 HUKU0253 HUKU0254 HUKU0266 HUKU0280 HUKU0283 HUKU0284 HUKU0290 HUKU0293 HUKU0294 HUKU0298 HUKU0312 HUKU0339 HUKU0340 HUKU0344 HUKU0354 HUKV0549 HUKV0576 HUKW0148 Product Name:Hickman 12 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600620CE UDI code: (01)00801741051913(17)291028(10)HUJY0302 (01)00801741051913(17)291028(10)HUJY1095 (01)00801741051913(17)291128(10)HUJZ1332 (01)00801741051913(17)291128(10)HUJZ1336 (01)00801741051913(17)291128(10)HUJZ1339 (01)00801741051913(17)291128(10)HUJZ1340 (01)00801741051913(17)300328(10)HUKR1349 (01)00801741051913(17)300328(10)HUKR1364 (01)00801741051913(17)300428(10)HUKS0784 (01)00801741051913(17)300428(10)HUKS0806 (01)00801741051913(17)300428(10)HUKS1217 (01)00801741051913(17)230428(10)HUKS1218 (01)00801741051913(17)300628(10)HUKU0259 (01)00801741051913(17)300628(10)HUKU0351 (01)00801741051913(17)300728(10)HUKV0349 (01)00801741051913(17)300728(10)HUKV0567 (01)00801741051913(17)300828(10)HUKW0534 Lot Number: HUJY0302 HUJY1095 HUJZ1332 HUJZ1336 HUJZ1339 HUJZ1340 HUKR1349 HUKR1364 HUKS0784 HUKS0806 HUKS1217 HUKS1218 HUKU0259 HUKU0351 HUKV0349 HUKV0567 HUKW0534 Product Name:Hickman 12.5 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600650CE UDI code: (01)00801741051975(17)300228(10)HUKQ0535 (01)00801741051975(17)300428(10)HUKS1474 (01)00801741051975(17)300428(10)HUKS1483 (01)00801741051975(17)300628(10)HUKU0313 (01)00801741051975(17)300628(10)HUKU0317 (01)00801741051975(17)300628(10)HUKU0328 (01)00801741051975(17)300728(10)HUKV0354 (01)00801741051975(17)300728(10)HUKV0371 (01)00801741051975(17)300828(10)HUKW0171 (01)00801741051975(17)300828(10)HUKW1283 Lot Number: HUKQ0535 HUKS1474 HUKS1483 HUKU0313 HUKU0317 HUKU0328 HUKV0354 HUKV0371 HUKW0171 HUKW1283 Product Name:Hickman 10 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0606560CE UDI code: (01)00801741052019(17)290828(10)HUKR1370 (01)00801741052019(17)290928(10)HUKS1219 (01)00801741052019(17)300128(10)HUKU0255 (01)00801741052019(17)290928(10)HUKU0324 (01)00801741052019(17)300128(10)HUKV0578 (01)00801741052019(17)300128(10)HUKW0172 (01)00801741052019(17)300128(10)HUKW1315 Lot Number: HUKR1370 HUKS1219 HUKU0255 HUKU0324 HUKV0578 HUKW0172 HUKW1315. A RECORDED FDA enforcement action (occurred=true).", "claimType": "official_fact", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": true, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "SourceCitation", "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1367-2026&lang=eng", "value": "Devices recall, status Ongoing", "adjudicator": { "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1367-2026&lang=eng" } }, "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." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1367-2026/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1367-2026 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.", "claimType": "regulatory_determination", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": true, "operative": true }, "grounding": { "groundingType": "AdjudicativeAct", "source": "U.S. FDA recall classification (openFDA enforcement)", "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1367-2026&lang=eng", "value": "Class II", "adjudicator": { "name": "U.S. FDA recall classification (openFDA enforcement)", "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1367-2026&lang=eng" } }, "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." }, { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1367-2026/boundary", "@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.", "claimType": "interpretation", "reviewStatus": "current", "commercialInfluence": false, "epistemicStatus": { "occurred": false, "supported": true, "adjudged": false, "operative": true }, "grounding": { "groundingType": "Interpretation", "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)", "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "value": "a recorded enforcement action, not proof of harm or causation; not medical advice", "adjudicator": null }, "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." } ], "hasPart": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-1367-2026", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1367-2026", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 2, "item": { "Field": "Product type", "Value": "Devices", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 3, "item": { "Field": "Classification", "Value": "Class II", "Status": "determination" } }, { "@type": "schema:ListItem", "position": 4, "item": { "Field": "Status", "Value": "Ongoing — the recall is still being carried out.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 5, "item": { "Field": "Recalling firm", "Value": "Bard Peripheral Vascular Inc", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "Due to damage to outer tray that can potentially compromise the sterile barrier", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2025-12-12", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "Product Name: Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600060 UDI code: (01)00801741051692(17)300728(10)HUKV0547 Lot Number: HUKV0547 Product Name: Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600100 UDI code: (01)00801741051708(17)300628(10)HUKU0307 (01)00801741051708(17)300828(10)HUKW1312 Lot Number: HUKU0307 HUKW1312 Product Name: Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray (Short External Length) with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600120 UDI code: (01)00801741051715(17)300628(10)HUKU0274 Lot Number: HUKU0274 Product Name: Hickman 7 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600310 UDI code: (01)00801741051739(17)300428(10)HUKS0783 (01)00801741051739(17)300628(10)HUKU0250 (01)00801741051739(17)300628(10)HUKU0310 Lot Number: HUKS0783 HUKU0250 HUKU0310 Product Name: Hickman 12 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600350 UDI code: (01)00801741051777(17)300428(10)HUKR1359 (01)00801741051777(17)300428(10)HUKS0811 (01)00801741051777(17)300628(10)HUKU0316 Lot Number: HUKR1359 HUKS0811 HUKU0316 Product Name:Broviac 4.2 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 600520 UDI code: (01)00801741051807(17)270528(10)HUKS1468 (01)00801741051807(17)270528(10)HUKU0246 (01)00801741051807(17)270528(10)HUKU0278 (01)00801741051807(17)270528(10)HUKU0289 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Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600100CE UDI code: (01)00801741051708(17)300628(10)HUKU0307 (01)00801741051708(17)300828(10)HUKW1312 Lot Number: HUKU0307 HUKW1312 Product Name:Hickman 7 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600310CE UDI code: (01)00801741051739(17)300428(10)HUKS0783 (01)00801741051739(17)300628(10)HUKU0250 (01)00801741051739(17)300628(10)HUKU0310 Lot Number: HUKS0783 HUKU0250 HUKU0310 Product Name:Broviac 4.2 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600520CE UDI code: (01)00801741051807(17)270528(10)HUKS1468 (01)00801741051807(17)270528(10)HUKU0246 (01)00801741051807(17)270528(10)HUKU0278 (01)00801741051807(17)270528(10)HUKU0289 (01)00801741051807(17)270528(10)HUKU0305 (01)00801741051807(17)270528(10)HUKU0338 (01)00801741051807(17)270528(10)HUKU0353 (01)00801741051807(17)270528(10)HUKW0164 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Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600560CE UDI code: (01)00801741051845(17)290828(10)HUKS0776 (01)00801741051845(17)290828(10)HUKS0816 (01)00801741051845(17)290928(10)HUKS1220 (01)00801741051845(17)290928(10)HUKU0302 (01)00801741051845(17)290928(10)HUKU0311 (01)00801741051845(17)300128(10)HUKU0345 (01)00801741051845(17)300128(10)HUKU0350 (01)00801741051845(17)300128(10)HUKV0555 Lot Number: HUKS0776 HUKS0816 HUKS1220 HUKU0302 HUKU0311 HUKU0345 HUKU0350 HUKV0555 Product Name:Hickman 7 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600570CE UDI code: (01)00801741051869(17)290628(10)HUKR1342 (01)00801741051869(17)290628(10)HUKR1344 (01)00801741051869(17)300128(10)HUKR1346 (01)00801741051869(17)290628(10)HUKR1347 (01)00801741051869(17)300128(10)HUKR1348 (01)00801741051869(17)300128(10)HUKR1356 (01)00801741051869(17)290628(10)HUKR1363 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HUKR1342 HUKR1344 HUKR1346 HUKR1347 HUKR1348 HUKR1356 HUKR1363 HUKR1367 HUKR1368 HUKS0774 HUKU0238 HUKU0242 HUKU0247 HUKU0253 HUKU0254 HUKU0266 HUKU0280 HUKU0283 HUKU0284 HUKU0290 HUKU0293 HUKU0294 HUKU0298 HUKU0312 HUKU0339 HUKU0340 HUKU0344 HUKU0354 HUKV0549 HUKV0576 HUKW0148 Product Name:Hickman 12 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600620CE UDI code: (01)00801741051913(17)291028(10)HUJY0302 (01)00801741051913(17)291028(10)HUJY1095 (01)00801741051913(17)291128(10)HUJZ1332 (01)00801741051913(17)291128(10)HUJZ1336 (01)00801741051913(17)291128(10)HUJZ1339 (01)00801741051913(17)291128(10)HUJZ1340 (01)00801741051913(17)300328(10)HUKR1349 (01)00801741051913(17)300328(10)HUKR1364 (01)00801741051913(17)300428(10)HUKS0784 (01)00801741051913(17)300428(10)HUKS0806 (01)00801741051913(17)300428(10)HUKS1217 (01)00801741051913(17)230428(10)HUKS1218 (01)00801741051913(17)300628(10)HUKU0259 (01)00801741051913(17)300628(10)HUKU0351 (01)00801741051913(17)300728(10)HUKV0349 (01)00801741051913(17)300728(10)HUKV0567 (01)00801741051913(17)300828(10)HUKW0534 Lot Number: HUJY0302 HUJY1095 HUJZ1332 HUJZ1336 HUJZ1339 HUJZ1340 HUKR1349 HUKR1364 HUKS0784 HUKS0806 HUKS1217 HUKS1218 HUKU0259 HUKU0351 HUKV0349 HUKV0567 HUKW0534 Product Name:Hickman 12.5 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0600650CE UDI code: (01)00801741051975(17)300228(10)HUKQ0535 (01)00801741051975(17)300428(10)HUKS1474 (01)00801741051975(17)300428(10)HUKS1483 (01)00801741051975(17)300628(10)HUKU0313 (01)00801741051975(17)300628(10)HUKU0317 (01)00801741051975(17)300628(10)HUKU0328 (01)00801741051975(17)300728(10)HUKV0354 (01)00801741051975(17)300728(10)HUKV0371 (01)00801741051975(17)300828(10)HUKW0171 (01)00801741051975(17)300828(10)HUKW1283 Lot Number: HUKQ0535 HUKS1474 HUKS1483 HUKU0313 HUKU0317 HUKU0328 HUKV0354 HUKV0371 HUKW0171 HUKW1283 Product Name:Hickman 10 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff Product Catalog Number: 0606560CE UDI code: (01)00801741052019(17)290828(10)HUKR1370 (01)00801741052019(17)290928(10)HUKS1219 (01)00801741052019(17)300128(10)HUKU0255 (01)00801741052019(17)290928(10)HUKU0324 (01)00801741052019(17)300128(10)HUKV0578 (01)00801741052019(17)300128(10)HUKW0172 (01)00801741052019(17)300128(10)HUKW1315 Lot Number: HUKR1370 HUKS1219 HUKU0255 HUKU0324 HUKV0578 HUKW0172 HUKW1315", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Worldwide - U.S. Nationwide distribution including in the states of 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, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Brazil, Canada, Chile, Hong Kong, India, Japan, Korea, Mexico, Malaysia, Singapore, Thailand, Uruguay, Vietnam.", "Status": "recorded" } } ] } ] }