THERASPHERE ADMINISTRATION SET (2021-07-23)
- Starting date:
- July 23, 2021
- Posting date:
- August 6, 2021
- 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-76171
Last updated:
2021-08-06
Affected Products
THERASPHERE ADMINISTRATION SET
Reason
Boston Scientific is initiating a Product Advisory for specific lots of TheraSphereTM Administration Sets to reinforce the existing administration set assembly instructions within the instructions for use (IFU), which state to firmly connect the outlet luer to the patient catheter. This Product Advisory will also inform users of the potential for leaks at this connection.
Affected products
THERASPHERE ADMINISTRATION SET
Lot or serial number
001E
002E
004E
005E
006E
007E
114E
690E
692E
Model or catalog number
OTT-SPE-FP-226
Companies
- Manufacturer
-
Biocompatibles UK Limited,
Chapman House, Farnham Business Park,
Farnham, Surrey, Great Britain
GU9 8QL