This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Nutriline, Catheter With Stylet And Microflash
- Starting date:
- July 12, 2017
- Posting date:
- August 15, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-64210
Reason
Two Vygon Nutriline kits are being recalled because it was found that they were packaged with an incorrect version of the microflash introducer. The version packaged in the affected product is a CE-marked version that is not yet cleared in the us or licensed in Canada. The change of introducer insider the Nutriline kits was made in error, as the un-licensed introducer was not approved to be in the Nutriline kits.
Affected products
Nutriline, Catheter With Stylet And Microflash
Lot or serial number
17D035D
Model or catalog number
1252.030G
Companies
- Manufacturer
-
VYGON US DBA VYGON CORPORATION, DBA CHURCHILL MEDICAL SYSTEMS
2750 MORRIS ROAD
Lansdale
19446
Pennsylvania
UNITED STATES