This page has been archived on the Web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.
DC Bead M1 Embolic Drug-Eluting Bead (2014-11-21)
- Starting date:
- November 21, 2014
- Posting date:
- November 28, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-42711
Recalled Products
DC Bead M1 Embolic Drug-Eluting Bead
Reason
Biocompatibles UK Ltd. is notifying customers of four additional potential complications that were not implemented in the instruction for use document supplied with the product, DC Bead M1, as agreed to with health Canada on October 18, 2013. These complications were: liver abscess, post embolization syndrome, pancreatitis and tumor rupture.
Affected products
DC Bead M1 Embolic Drug-Eluting Bead
Lot or serial number
V10503
V10561
V10569
V10582
V10598
V10692
V10705
Model or catalog number
CE020GS
Companies
- Manufacturer
-
Biocompatibles UK Limited,
Chapman House, Farnham Business Park,
Farnham, Surrey, Great Britain
GU9 8QL