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    The document alerts healthcare organizations that a previously suspended medical device, the Arrow 3 FG PICC line, can now be used safely provided the amended product instructions are followed. An investigation found the product itself was not faulty but the instructions needed improvement. Attached are the updated product instructions and a tips poster, with special attention needed on catheter trimming as outlined.

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    The document alerts healthcare organizations that a previously suspended medical device, the Arrow 3 FG PICC line, can now be used safely provided the amended product instructions are followed. An investigation found the product itself was not faulty but the instructions needed improvement. Attached are the updated product instructions and a tips poster, with special attention needed on catheter trimming as outlined.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    10 views10 pages

    Arrow

    Uploaded by

    000009
    The document alerts healthcare organizations that a previously suspended medical device, the Arrow 3 FG PICC line, can now be used safely provided the amended product instructions are followed. An investigation found the product itself was not faulty but the instructions needed improvement. Attached are the updated product instructions and a tips poster, with special attention needed on catheter trimming as outlined.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
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    Dear Chief Executives, A Safety Alert (SA:002/08) on Peripherally Inserted Central Catheter (PICC) Line - Arrow 3 FG Brand (PC-01351-TW,

    All lot numbers) was sent out on 13 October 2008 advising AHSs to inform hospitals to suspend use of the device until further notice. The Therapeutic Goods Administration (TGA) has undertaken an investigation with the manufacturer of this product and have advised there is no fault with the product, however it was identified that the product instructions needed to be improved. The amended Product Instructions and "Tips for Practice" poster are attached. The product distributor has also mailed a copy of these documents directly to each hospital. You are now advised that it is safe to use this product, provided the attached product instructions are followed. Clinicians need to take particular note of the Catheter Trimming instructions outlined on the "Tips for Practice" poster. Thank you Kelvin Genn Director, Quality and Safety Branch

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