Product Wiki · Recalls · Health Canada — Medical Devices

XCELA PICC WITH PASV VALVE TECHNOLOGY, SINGLE LUMEN, IR KIT, BIOFLOW… — recall 59839

Health Canada — Medical Devices · Canada · 2019-08-02 · Type II

As described by Health Canada — Medical Devices: XCELA PICC WITH PASV VALVE TECHNOLOGY, SINGLE LUMEN, IR KIT, BIOFLOW PICC MST-70 KIT, BIOFLOW PICC IR-175 KIT, PICC CONVENIENCE KIT (2018-05-10)

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Agency
Health Canada — Medical Devices
Recall identifier
59839
Date of alert
2019-08-02
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: AngioDynamics, Inc., Is conducting a medical device recall to the end user level based on information received from Galt Medical Corp., the manufacturer of certain introducers sheaths included within AngioDynamics Procedure Kits. Galt Medical Corp. has determined that the products listed in their 2-May-2018 recall notification, "might contain unsafe levels of bacterial endotoxins (pyrogens) that were introduced during a manufacturing step." As stated in the Recall Notification from Galt Medical, "Bacterial Endotoxins, also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient. AngioDynamics has confirmed that introducer sheaths affected by this recall have been included within AngioDynamics Procedure Kits which have been distributed to end users. AngioDynamics began distributing product affected by this recall on February 28, 2018 worldwide.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/xcela-picc-pasv-valve-technolo

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