Percutaneous Sheath Introducer Procedural Kits with Silk Sutures (2018-04-13)
- Starting date:
- April 13, 2018
- Posting date:
- May 11, 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-66728
Affected products
- PERCUTANEOUS SHEATH INTRODUCER PROCEDURAL KITS WITH SILK SUTURES
- INTRODUCER NEEDLES
- ARROWG+ARD CENTRAL VENOUS CATHETERIZATION KIT
- FLAT EPIDURAL FILTER
- SNAPLOCK CATHETER/SYRINGE ADAPTER
- SPRING WIRE GUIDE INTRODUCER CATHETER ASSEMBLY
- THERACATH SPRING WIRE EPIDURAL CATHETER
- CONTINUOUS EPIDURAL NEEDLE
- PERCUTANEOUS SHEATH INTRODUCER PROCEDURAL KITS
- ARROWG+ARD BLUE PLUS WITH BLUE FLEX TIP DOUBLE LUMEN CVC KIT
- ARROWG+ARD BLUE PLUS(R) W/BLUE FLEXTIP(R) TRIPLE LUMEN CVC KIT
- LOSS OF RESISTANCE SYRINGE
- CONTINUOUS NERVE BLOCK NEEDLES
- ARROWG+ARD BLUE PLUS ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATH. SET
- CG+ ARROW PICC WITH CHLORAG+ARD TECHNOLOGY, NO PLACEMENT WIRE
- ARROW-JOHANS RIGHT ATRIAL ELECTROCARDIOGRAPHY (RAECG) ADAPTER
- VPS RHYTHM ECG ACCESSORY PACK
- VPS TIPTRACKER STYLET ACCESSORY
- MAXIMAL BARRIER DRAPE
- CATHETER CLAMP WITH FASTENER
- ACCESSORY KIT, SHEATH ADAPTER WIT CATH-GARD CONTAMINATION SHIELD
- EXTERNAL LINE SLIDE CLAMP COMPONENT
Reason
Arrow International is recalling the product because the packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. If a non-sterile product is used, there is potential for infection to occur. No patient injuries have been reported related to this issue.
Affected products
A. PERCUTANEOUS SHEATH INTRODUCER PROCEDURAL KITS WITH SILK SUTURES
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
ASK-09907-SB
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
B. INTRODUCER NEEDLES
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- AN-04318
- AN-04320
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
C. ARROWG+ARD CENTRAL VENOUS CATHETERIZATION KIT
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
ASK-24306-VC
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
D. FLAT EPIDURAL FILTER
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
EF-05500
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
E. SNAPLOCK CATHETER/SYRINGE ADAPTER
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
AS-05500
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
F. SPRING WIRE GUIDE INTRODUCER CATHETER ASSEMBLY
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
CN-04018
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
G. THERACATH SPRING WIRE EPIDURAL CATHETER
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
EC-05000
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
H. CONTINUOUS EPIDURAL NEEDLE
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- AN-05501
- AN-05505
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
I. PERCUTANEOUS SHEATH INTRODUCER PROCEDURAL KITS
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
ASK-09803-SRH
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
J. ARROWG+ARD BLUE PLUS WITH BLUE FLEX TIP DOUBLE LUMEN CVC KIT
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- ASK-42802-VC
- ASK-47702-VC
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
K. ARROWG+ARD BLUE PLUS(R) W/BLUE FLEXTIP(R) TRIPLE LUMEN CVC KIT
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- ASK-42703-RV1
- ASK-45703-VC
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
L. LOSS OF RESISTANCE SYRINGE
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
LR-05501
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
M. CONTINUOUS NERVE BLOCK NEEDLES
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- AB-17080-N
- AB-17140-N
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
N. ARROWG+ARD BLUE PLUS ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATH. SET
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
ASK-42703-VC
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
O. CG+ ARROW PICC WITH CHLORAG+ARD TECHNOLOGY, NO PLACEMENT WIRE
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- PR-45541-HPHNL
- PR-45541-HPHNM
- PR-45552-HPHNL
- PR-45552-HPHNM
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
P. ARROW-JOHANS RIGHT ATRIAL ELECTROCARDIOGRAPHY (RAECG) ADAPTER
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
EG-04900
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
Q. VPS RHYTHM ECG ACCESSORY PACK
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
RHY-100-ECGJ
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
R. VPS TIPTRACKER STYLET ACCESSORY
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
RHY-177-TTSAP
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
S. MAXIMAL BARRIER DRAPE
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
ASK-00002-1A
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
T. CATHETER CLAMP WITH FASTENER
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- CC-00004
- CC-00005
- CC-00007
- CC-00008
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
U. ACCESSORY KIT, SHEATH ADAPTER WIT CATH-GARD CONTAMINATION SHIELD
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
SA-09847
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
V. EXTERNAL LINE SLIDE CLAMP COMPONENT
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
SC-14703
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES