International Medical Devices Database

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

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Type of Event
Field Safety Notice
Date
2015-09-28
Event Country
Slovenia
Event Source
AMPMDRS
Notes / Alerts

Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
Arrow international, inc. (“arrow”) is notifying its customers that received the products referenced above; there is a labelling inaccuracy in the instructions for use (ifu) and patient card. the ifu and patient card contained within the these products state the picc can withstand up to ten (10) pressure injections, however, the picc has only been tested to withstand five (5) pressure injections. .

Device

Arrow® Pressure Injectable Peripherally Inserted Central Catheter (PICC) – 4FR

Model / Serial
ASK-05041-CHC2 EU-04041-HP EU-25041-IR PR-05041-HP ASK-05041-LM4 EU-04041-HPMSB EU-25541-HP PR-05041-HPX ASK-05041-QV EU-05041-HPMSB EU-25541-HPMSB PR-05541-HPX ASK-05541-MS3 EU-05541-HP EU-25541-IR UK-04041-RDE1 CA-05041-HP EU-05541-HPMSB FR-04041 UK-04041-THT CA-05041-HPX EU-24041-HP FR-04041-CF UK-05041-HPMIN CDC-04041-HPK1A EU-24041-HPMSB FR-05041 UK-05041-MSB CDC-05041-HPK1A EU-24041-IR FR-05041-CF UK-05041-RDE1 CDC-05541-HPK1A EU-25041-HP FR-05541-CF UK-05041-THT
Manufacturer
Arrow International Inc.

Manufacturer

Arrow International Inc.

Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
AMPMDRS

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Field Safety Notices about Arrow® Pressure Injectable Peripherally Inserted Central Catheter (PICC) – 4FR

What is this?

Device

Arrow® Pressure Injectable Peripherally Inserted Central Catheter (PICC) – 4FR

Manufacturer

Arrow International Inc.