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Health product recall

Xcela PICC with PASV Technology Convenience Kit (2017-10-17)

Starting date:
October 17, 2017
Posting date:
October 27, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-64972

Affected products

Xcela PICC with PASV Technology Convenience Kit

Reason

AngioDynamics, Inc. (dba Navilyst Medical. Inc.), the manufacturer of the Xcela PICC with PASV Technology Convenience Kit for centenary hospital (4f single lumen), is conducting a medical device recall to the end user level. AngioDynamics has determined that the affected product contains an inaccurate product description on the labelling, the product is labelled as 5f - 55cm and the product is actually 4f - 55cm. AngioDynamics began distributing product affected by this recall on July 14, 2017.

Affected products

Xcela PICC with PASV Technology Convenience Kit

Lot or serial number
  • 5210162
  • 5228251
Model or catalog number

H96560M7XXXXXX

Companies
Manufacturer
Navilyst Medical, Inc.
26 Forest Street
Marlborough
01752
Massachusetts
UNITED STATES