Arrow Internationals' various Central Venous Catheterization Kits/Sets, Central Venous Cather Kits/Sets, Pressure Injectable PICC Kits/Sets and Percutaneous Sheath Introducer Set (2017-12-22)
- Starting date:
- December 22, 2017
- Posting date:
- January 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-65694
Affected products
- ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION SET
- PERCUTANEOUS SHEATH INTRODUCER SET WITH ARROWG+ARD BLUE SHEATH
- PRESSURE INJECTABLE PICC KIT
- ARROWG+ARD BLUE PLUS(R) W/BLUE FLEXTIP(R) TRIPLE LUMEN CVC KIT
- AGB+ PRESSURE INJECTABLE MULTI-LUMEN CVC KIT
- AGB+ PRESSURE INJECTABLE QUAD-LUMEN CVC KIT
- PERCUTANEOUS SHEATH INTRODUCER KIT WITH ARROWG+ARD BLUE(R) SHEATH, INTEGRAL HEMOSTASIS VALVE/SIDE PORT, AND MAXIMAL BARRIER PRECAUTIONS
- ARROWG+ARD BLUE MAC TWO-LUMEN CENTRAL VENOUS ACCESS KIT
- ARROWG+ARD BLUE YOU-BEND TWO-LUMEN HEMODIALYSIS CATHETERIZATION KIT HIGH VOLUME INFUSIONS
- PRESSURE INJECTABLE MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT
Reason
Arrow International is recalling this product because the packaging may not be completely 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.
Affected products
A. ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION SET
Lot or serial number
- 13F17B0279
- 13F17D0112
- 13F17F0575
Model or catalog number
- ASK-12703-PRJ
- ASK-15703-PRJ
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
B. PERCUTANEOUS SHEATH INTRODUCER SET WITH ARROWG+ARD BLUE SHEATH
Lot or serial number
- 13F17D0188
- 13F17E0570
Model or catalog number
ASK-29804-UHN2
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
C. PRESSURE INJECTABLE PICC KIT
Lot or serial number
13F17B0123
Model or catalog number
EU-05052-HPMSB
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
D. ARROWG+ARD BLUE PLUS(R) W/BLUE FLEXTIP(R) TRIPLE LUMEN CVC KIT
Lot or serial number
- 13F16M0019
- 13F17A0296
- 13F17B0343
- 13F17D0110
- 13F17D0113
- 13F17F0319
Model or catalog number
- ASK-42703-PRJ
- ASK-45703-PRJ
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
E. AGB+ PRESSURE INJECTABLE MULTI-LUMEN CVC KIT
Lot or serial number
- 13F17A0022
- 13F17A0157
- 13F17A0167
- 13F17A0301
- 13F17B0117
- 13F17B0145
- 13F17B0152
- 13F17C0057
- 13F17C0250
- 13F17C0266
- 13F17C0318
- 13F17C0466
- 13F17D0039
- 13F17E0095
- 13F17F0261
Model or catalog number
- CA-42703-P1A
- CA-45703-P1A
- CDA 42802-P1A
- CDA-42703-P1A
- CDA-45703-P1A
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
F. AGB+ PRESSURE INJECTABLE QUAD-LUMEN CVC KIT
Lot or serial number
- 13E17D0283
- 13F16M0048
- 13F17C0325
- 13F17E0124
- 13F17E0796
- 13F17F0071
- 13F17F0226
- 13F17F0497
Model or catalog number
- ASK-42854-PRJ
- CA-42854-P1A
- CA-45854-P1A
- CDA-42854-P1A
- CDA-45854-P1A
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
G. PERCUTANEOUS SHEATH INTRODUCER KIT WITH ARROWG+ARD BLUE(R) SHEATH, INTEGRAL HEMOSTASIS VALVE/SIDE PORT, AND MAXIMAL BARRIER PRECAUTIONS
Lot or serial number
- 13F17C0267
- 13F17E0385
Model or catalog number
CDA-29803-1A
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
H. ARROWG+ARD BLUE MAC TWO-LUMEN CENTRAL VENOUS ACCESS KIT
Lot or serial number
13F17F0437
Model or catalog number
CDA-21242-1A
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
I. ARROWG+ARD BLUE YOU-BEND TWO-LUMEN HEMODIALYSIS CATHETERIZATION KIT HIGH VOLUME INFUSIONS
Lot or serial number
- 13F16M0184
- 13F17C0267
- 13F17E0616
- 13F17F0256
Model or catalog number
- CDA-22122-U1A
- CDA-25122-U1A
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES
J. PRESSURE INJECTABLE MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT
Lot or serial number
- 13F17F0240
- 13F17F0575
Model or catalog number
- ASK-12703-PCA
- ASK-15703-PCA
Companies
- Manufacturer
-
Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES