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Health product recall

Unlicensed Dynarex Products (2016-02-15)

Starting date:
February 15, 2016
Posting date:
April 22, 2016
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-58018

Affected Products

A. 4806 SUCTION CATHETERS - STERILE 6 FR, PEDIATRIC
B. 4808 SUCTION CATHETERS - STERILE 8FR, PEDIATRIC
C. 4810 SUCTION CATHETERS - 10 FR.
D. 4812 SUCTION CATHETERS - 12 FR.
E. 4814 SUCTION CATHETERS - 14 FR.
F. 4816 SUCTION CATHETERS - 16 FR.
G. 4818 SUCTION CATHETERS - 18 FR.
H. 4832 SUCTION CATHETERS KITS, 12 FR.
I. 4914 VAGINAL SPECULUM - S
J. 4916 VAGINAL SPECULUM - L
K. 5105 PXYGEN TUBING - NO CRUSH LUMEN - 25 FT
L. 5201 SOF-TOUCH NASAL CANNULAS, INFANT
M. 5202 SOF-TOUCH NASAL CANNULAS, PEDIATRIC
N. 5203 SOF-TOUCH NASAL CANNULAS, ADULT
O. 5205 STANDARD NASAL CANNULAS, ADULT STRAIGHT TIP
P. 5206 STANDARD NASAL CANNULAS, ADULT STRAIGHT TIP
Q. 5207 STANDARD NASAL CANNULAS, ADULT, FLARED CURBE
R. 5302 OXYGEN MASK, ELONGATED, ADULT
S. 5303 OXYGEN MASK, ELONGATED, ADULT
T. 5602 NEBULIZER WITH "T" PIECE, MOUTH PIECE
U. 5604 NEBULIZER WITH ADULT AEROSOL MASK

Reason

The listed devices are recalled because they were found to be unlicensed in Canada.

Affected products

A. 4806 SUCTION CATHETERS - STERILE 6 FR, PEDIATRIC

Lot or serial number

All lots.

Model or catalog number

4806

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

B. 4808 SUCTION CATHETERS - STERILE 8FR, PEDIATRIC

Lot or serial number

All lots.

Model or catalog number

4808

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

C. 4810 SUCTION CATHETERS - 10 FR.

Lot or serial number

All lots.

Model or catalog number

4810

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

D. 4812 SUCTION CATHETERS - 12 FR.

Lot or serial number

All lots.

Model or catalog number

4812

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

E. 4814 SUCTION CATHETERS - 14 FR.

Lot or serial number

All lots.

Model or catalog number

4814

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

F. 4816 SUCTION CATHETERS - 16 FR.

Lot or serial number

All lots.

Model or catalog number

4816

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

G. 4818 SUCTION CATHETERS - 18 FR.

Lot or serial number

All lots.

Model or catalog number

4818

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

H. 4832 SUCTION CATHETERS KITS, 12 FR.

Lot or serial number

All lots.

Model or catalog number

4832

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

I. 4914 VAGINAL SPECULUM - S

Lot or serial number

All lots.

Model or catalog number

4914

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

J. 4916 VAGINAL SPECULUM - L

Lot or serial number

All lots.

Model or catalog number

4916

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

K. 5105 PXYGEN TUBING - NO CRUSH LUMEN - 25 FT

Lot or serial number

All lots.

Model or catalog number

5105

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

L. 5201 SOF-TOUCH NASAL CANNULAS, INFANT

Lot or serial number

All lots.

Model or catalog number

5201

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

M. 5202 SOF-TOUCH NASAL CANNULAS, PEDIATRIC

Lot or serial number

All lots.

Model or catalog number

5202

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

N. 5203 SOF-TOUCH NASAL CANNULAS, ADULT

Lot or serial number

All lots.

Model or catalog number

5203

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

O. 5205 STANDARD NASAL CANNULAS, ADULT STRAIGHT TIP

Lot or serial number

All lots.

Model or catalog number

5205

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

P. 5206 STANDARD NASAL CANNULAS, ADULT STRAIGHT TIP

Lot or serial number

All lots.

Model or catalog number

5206

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

Q. 5207 STANDARD NASAL CANNULAS, ADULT, FLARED CURBE

Lot or serial number

All lots.

Model or catalog number

5207

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

R. 5302 OXYGEN MASK, ELONGATED, ADULT

Lot or serial number

All lots.

Model or catalog number

5302

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

S. 5303 OXYGEN MASK, ELONGATED, ADULT

Lot or serial number

All lots.

Model or catalog number

5303

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

T. 5602 NEBULIZER WITH "T" PIECE, MOUTH PIECE

Lot or serial number

Tous les lots.

Model or catalog number

5602

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES

U. 5604 NEBULIZER WITH ADULT AEROSOL MASK

Lot or serial number

All lots.

Model or catalog number

5604

Companies
Manufacturer
Dynarex Corporation
10 Glenshaw Street
Orangeburg
10962
New York
UNITED STATES