{
  "format": "devicerts.device.v1",
  "cite_as": "Arrow IPN032846, Teleflex Incorporated. deviCERTS medical device catalogue. https://devicerts.com/devices/arrow-ask-45041-brz (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/arrow-ask-45041-brz",
    "json_url": "https://devicerts.com/devices/arrow-ask-45041-brz.json",
    "markdown_url": "https://devicerts.com/devices/arrow-ask-45041-brz.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-14",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/arrow-ask-45041-brz",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Arrow IPN032846",
    "registry_name": "ARROW IPN032846",
    "url": "https://devicerts.com/devices/arrow-ask-45041-brz",
    "manufacturer": {
      "name": "Teleflex Incorporated",
      "url": "https://devicerts.com/manufacturers/teleflex-incorporated",
      "country": null,
      "country_basis": null,
      "fda_registration_country": "United States"
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Catalogue number",
        "values": [
          {
            "value": "ASK-45041-BRZ",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "00801902094636",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K112896",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "LJS"
    ],
    "emdn": [],
    "gmdn": [
      {
        "code": "36257",
        "term": "Peripherally-inserted central venous catheter"
      }
    ],
    "description": null,
    "noindex": true
  },
  "authorizations": [
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "00801902094636",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2015-10-16",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K112896",
      "number_label": null,
      "device_udi_di": null,
      "date": "2012-05-10",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-2378-2026",
      "classification": "Class I",
      "status": "ongoing",
      "initiated": "2026-04-21",
      "reason": "Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.",
      "applies": "this device",
      "via": "K112896"
    },
    {
      "number": "Z-1822-2019",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-04-23",
      "reason": "Lidstock states the incorrect expiration date for the product",
      "applies": "this device",
      "via": "K112896"
    },
    {
      "number": "Z-1820-2019",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-04-23",
      "reason": "Lidstock states the incorrect expiration date for the product",
      "applies": "this device",
      "via": "K112896"
    },
    {
      "number": "Z-1811-2019",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-04-23",
      "reason": "Lidstock states the incorrect expiration date for the product",
      "applies": "this device",
      "via": "K112896"
    },
    {
      "number": "Z-1819-2019",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-04-23",
      "reason": "Lidstock states the incorrect expiration date for the product",
      "applies": "this device",
      "via": "K112896"
    },
    {
      "number": "Z-1327-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-12-22",
      "reason": "Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.",
      "applies": "shared submission",
      "via": "K112896"
    },
    {
      "number": "Z-0996-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-11-27",
      "reason": "Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.",
      "applies": "this device",
      "via": "K112896"
    },
    {
      "number": "Z-2698-2017",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-06-12",
      "reason": "Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter.",
      "applies": "this device",
      "via": "K112896"
    },
    {
      "number": "Z-2331-2017",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-05-09",
      "reason": "Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.",
      "applies": "this device",
      "via": "K112896"
    },
    {
      "number": "Z-1705-2017",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-03-03",
      "reason": "Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC-45541-HPK1A on the banner card. The affected lot numbers are 23F16C0851, 23F16A0727, and 23F16C0844.",
      "applies": "this device",
      "via": "K112896"
    },
    {
      "number": "Z-0207-2016",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2015-10-16",
      "reason": "Possibility that the catheter peel-away\ncomponent hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the\ncatheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment\nwhen placing the catheter.",
      "applies": "this device",
      "via": "K112896"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Trade name",
          "values": [
            {
              "value": "ARROW",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Generic name",
          "values": [
            {
              "value": "Peripherally-inserted central venous catheter",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Model / Ref / Catalog",
          "values": [
            {
              "value": "IPN032846",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            },
            {
              "value": "ASK-45041-BRZ",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "Primary DI / UDI-DI",
          "values": [
            {
              "value": "00801902094636",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K112896",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "LJS",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "GMDN term",
          "values": [
            {
              "value": "Peripherally-inserted central venous catheter",
              "code": "36257",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Regulation number",
          "values": [
            {
              "value": "880.5970",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "GUDID distribution status",
          "values": [
            {
              "value": "In Commercial Distribution",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Properties",
      "fields": [
        {
          "label": "Supplied sterile",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Single use",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Implantable",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Prescription use",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Convenience kit",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Lot / batch number",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Expiration date",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Sterilise before use",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Contains latex",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Over-the-counter",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Combination product",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "HCT/P",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Premarket exempt",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Serial number",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Manufacturing date",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    }
  ]
}