TLAB Transjugular Liver Biopsy System (2020-12-14)
- Starting date:
- December 14, 2020
- Posting date:
- January 12, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-74737
Last updated:
2021-01-12
Affected Products
TLAB Transjugular Liver Biopsy System
Reason
The distal tip of the introducer sheath can separate during use if the tip is flexed or experiences bending stresses, potentially coming loose inside the patient, due to a manufacturing error.
Affected products
TLAB Transjugular Liver Biopsy System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- TL-18C
- TL-18N
- TL-18S
- TL-19
- TL-19N
Companies
- Manufacturer
-
Argon Medical Devices Inc.
1445 Flat Creek Road
Athens
75751
Texas
UNITED STATES