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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