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

A. ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION SET
B. PERCUTANEOUS SHEATH INTRODUCER SET WITH ARROWG+ARD BLUE SHEATH
C. PRESSURE INJECTABLE PICC KIT
D. ARROWG+ARD BLUE PLUS(R) W/BLUE FLEXTIP(R) TRIPLE LUMEN CVC KIT
E. AGB+ PRESSURE INJECTABLE MULTI-LUMEN CVC KIT
F. AGB+ PRESSURE INJECTABLE QUAD-LUMEN CVC KIT
G. PERCUTANEOUS SHEATH INTRODUCER KIT WITH ARROWG+ARD BLUE(R) SHEATH, INTEGRAL HEMOSTASIS VALVE/SIDE PORT, AND MAXIMAL BARRIER PRECAUTIONS
H. ARROWG+ARD BLUE MAC TWO-LUMEN CENTRAL VENOUS ACCESS KIT
I. ARROWG+ARD BLUE YOU-BEND TWO-LUMEN HEMODIALYSIS CATHETERIZATION KIT HIGH VOLUME INFUSIONS
J. PRESSURE INJECTABLE MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION KIT

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.

 

13F17B0279
13F17D0112
13F17F0575

ASK-12703-PRJ
ASK-15703-PRJ

Manufacturer

Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

 

 

13F17D0188
13F17E0570
 

ASK-29804-UHN2

Manufacturer

Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

 

 

13F17B0123

EU-05052-HPMSB

Manufacturer

Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

 

 

13F16M0019
13F17A0296
13F17B0343
13F17D0110
13F17D0113
13F17F0319

ASK-42703-PRJ
ASK-45703-PRJ

Manufacturer

Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

 

 

13F17A0022
13F17A0157
13F17A0167
13F17A0301
13F17B0117
13F17B0145
13F17B0152
13F17C0057
13F17C0250
13F17C0266
13F17C0318
13F17C0466
13F17D0039
13F17E0095
13F17F0261

CA-42703-P1A
CA-45703-P1A
CDA 42802-P1A
CDA-42703-P1A
CDA-45703-P1A

Manufacturer

Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

 

 

13E17D0283
13F16M0048
13F17C0325
13F17E0124
13F17E0796
13F17F0071
13F17F0226
13F17F0497

ASK-42854-PRJ
CA-42854-P1A
CA-45854-P1A
CDA-42854-P1A
CDA-45854-P1A

Manufacturer

Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

 

 

13F17C0267
13F17E0385

CDA-29803-1A

Manufacturer

Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

 

 

13F17F0437

CDA-21242-1A

Manufacturer

Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

 

 

13F16M0184
13F17C0267
13F17E0616
13F17F0256

CDA-22122-U1A
CDA-25122-U1A
 

Manufacturer

Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

 

 

13F17F0240
13F17F0575

ASK-12703-PCA
ASK-15703-PCA
 

Manufacturer

Arrow International, Inc. (Subsidiary of Teleflex, Incorporated)
2400 Bernville Road
Reading
19605
Pennsylvania
UNITED STATES

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