Various B.Braun Medical Inc's Catheter Connector, Nerve Block Sets, Epidural Catheter Sets, Epidural Catheter Tray and Epidural Sets (2018-08-14)
- Starting date:
- August 14, 2018
- Posting date:
- October 19, 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-67906
Affected products
A. PERIFIX Clamp Style Catheter Connector
B. Contiplex Tuohy Continuous Nerve Block Sets
C. Contiplex Continuous Nerve Block Set
D. PERIFIX Epidural Catheter Sets
E. PERIFIX Continuous Epidural Sets
F. PERIFIX Continuous Pediatric Epidural Sets
G. PERIFIX FX Springwound Epidural Catheter Tray
H. PERIFIX Springwound FX Epidural Catheter Sets
I. PERIFIX ONE Pediatric Epidural Catheter Set
J. Contiplex Tuohy Ultra Continuous Nerve Block Set
K. CONTIPLEX C Continuous Peripheral Nerve Block Catheter Set
L. Contiplex Echo Continuous Nerve Block Set
Reason
B. Braun has identified a product defect in which there is a possibility that the connector may not remain closed during use. This has led to connector leakage or disconnection in some cases.
Affected products
A. PERIFIX Clamp Style Catheter Connector
Lot or serial number
All lots.
Model or catalog number
332283
332285
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
B. Contiplex Tuohy Continuous Nerve Block Sets
Lot or serial number
All lots.
Model or catalog number
331691
331693
331694
331695
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
C. 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
D. PERIFIX Epidural Catheter Sets
Lot or serial number
All lots.
Model or catalog number
333511
333520
333521
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
E. PERIFIX Continuous Epidural Sets
Lot or serial number
All lots.
Model or catalog number
332200
332202
332210
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
F. PERIFIX Continuous Pediatric Epidural Sets
Lot or serial number
All lots.
Model or catalog number
332291
332293
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
G. 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
H. PERIFIX Springwound FX Epidural Catheter Sets
Lot or serial number
All lots.
Model or catalog number
333512
333514
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
I. PERIFIX ONE Pediatric Epidural Catheter Set
Lot or serial number
All lots.
Model or catalog number
333538
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
J. Contiplex Tuohy Ultra Continuous Nerve Block Set
Lot or serial number
All lots.
Model or catalog number
333697
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
K. CONTIPLEX C Continuous Peripheral Nerve Block Catheter Set
Lot or serial number
All lots.
Model or catalog number
331761
331763
331766
331767
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES
L. Contiplex Echo Continuous Nerve Block Set
Lot or serial number
All lots.
Model or catalog number
331640
331641
331673
331674
Companies
- Manufacturer
-
B. Braun Medical Inc.
824 12th Avenue
Bethlehem
18018
UNITED STATES