Various B. Braun Medical's Catheter, Nerve Block, and Epidural Sets (2018-07-24)
- Starting date:
- July 24, 2018
- Posting date:
- August 17, 2018
- 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-67382
Affected products
- PERIFIX Clamp
- PERIFIX Next Generation Catheter Sets
- Contiplex Tuohy Continuous Nerve Block Sets
- Contiplex Continuous Nerve Block Set
- PERIFIX Epidural Catheter Sets
- PERIFIX Continuous Epidural Sets
- PERIFIX Continuous Pediatric Epidural Sets
- PERIFIX FX Springwound Epidural Catheter Tray
- Contiplex Tuohy Continuous Nerve Block Set
- Contiplex Echo Continuous Nerve Block Set
Reason
In the course of the regular post market surveillance activities the manufacturer has found that the Perifix Catheter Connector may not remain closed during use. In some cases this has led to leakage or disconnection of the catheter from the Perifix Catheter Connector.
Affected products
- PERIFIX Clamp
Lot or serial number
All lots.
Model or catalog number
332285
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
B. PERIFIX Next Generation Catheter Sets
Lot or serial number
All lots.
Model or catalog number
333541
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
C. Contiplex Tuohy Continuous Nerve Block Sets
Lot or serial number
All lots.
Model or catalog number
331693
331695
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
D. Contiplex Continuous Nerve Block Set
Lot or serial number
All lots.
Model or catalog number
331757
331758
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
E. PERIFIX Epidural Catheter Sets
Lot or serial number
All lots.
Model or catalog number
333511
333521
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
F. PERIFIX Continuous Epidural Sets
Lot or serial number
All lots.
Model or catalog number
332210
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
G. PERIFIX Continuous Pediatric Epidural Sets
Lot or serial number
All lots.
Model or catalog number
332293
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
H. PERIFIX FX Springwound Epidural Catheter Tray
Lot or serial number
All lots.
Model or catalog number
332238
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
I. Contiplex Tuohy Continuous Nerve Block Set
Lot or serial number
All lots.
Model or catalog number
331673
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
J. Contiplex Echo Continuous Nerve Block Set
Lot or serial number
All lots.
Model or catalog number
331767
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES