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| Issued: 21 July 2008 at 10:30 |
Ref: MDA/2008/051
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Immediate action |
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Action |
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Update |
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Information request |
| Device: Kimal safety fistula needle (all product codes and lots). |
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| Problem: Kimal is aware of the potential for the unintentional retraction of the cannula into the protection sheath, which can result in exsanguination. As a result, Kimal is recalling all lots of the device. |
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| Action by: All staff associated with performing dialysis and plasmapheresis treatments. |
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Action:
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Distributed to:
* via CE Bulletin |
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| Contacts: Details of manufacturer contacts and contacts for technical and clinical aspects. Change of address or removal from address list for CSCI and Healthcare Commission. |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 24 July 2008
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Deadline (action complete): 28 July 2008
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