Health product recall

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