Health product recall

Arrow International's various Central Venous Catheter Kits (2017-11-29)

Starting date:
November 29, 2017
Posting date:
January 8, 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-65558

Affected Products

A. ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION SET
B. ARROWG+ARD BLUE PLUS CENTRAL VENOUS CATHETER KITS
C. AGB+ PRESSURE INJECTABLE MULTI-LUMEN CVC KIT
D. AGB+ PRESSURE INJECTABLE QUAD-LUMEN CVC KIT
E. PERCUTANEOUS SHEATH INTRODUCER KIT WITH ARROWG+ARD BLUE(R) SHEATH
F.  TWO-LUMEN CENTRAL VENOUS ACCESS KIT
G. ARROWG+ARD BLUE LARGE BORE MULTI-LUMEN CVC KIT

Reason

Arrow International is recalling the referenced products because some of the products may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.

Affected products

A. ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION SET

Lot or serial number

13F17B0265
13F17B0279
13F17D0112

Model or catalog number

ASK-12703-PRJ
ASK15703-PRJ

Companies
Manufacturer
Arrow International Inc.
2400 Bernville Road
Reading
19605
UNITED STATES

B. ARROWG+ARD BLUE PLUS CENTRAL VENOUS CATHETER KITS

Lot or serial number

13F16L0007
13F16M0013
13F16M0019
13F17A0296
13F17B0343
13F17D0110
13F17D0113
13F17F0319
13F17G0059
13F17H0095

Model or catalog number

ASK-42703-PRJ
ASK-45703-PRJ

Companies
Manufacturer
Arrow International Inc.
2400 Bernville Road
Reading
19605
UNITED STATES

C. AGB+ PRESSURE INJECTABLE MULTI-LUMEN CVC KIT

Lot or serial number

13F16K0239
13F16K0306
13F16L0091
13F16L0092
13F16L0285
13F16M0047
13F17A0022
13F17A0157
13F17A0167
13F17A0301
13F17B0117
13F17B0145
13F17B0152
13F17B0249
13F17C0057
13F17C0174
13F17C0250
13F17C0266
13F17C0318
13F17C0466
13F17D0039
13F17E0095
13F17F0259
13F17F0261
13F17F0298
13F17F0299
13F17G0090
13F17G0541
13F17H0068
13F17H0071
13F17H0096
13F17H0100
13F17H0566

Model or catalog number

CA-42703-P1A
CA-45703-P1A
CDA-42703-P1A
CDA-42802-P1A
CDA-45703-P1A
CDA-47702-P1A

Companies
Manufacturer
Arrow International Inc.
2400 Bernville Road
Reading
19605
UNITED STATES

D. AGB+ PRESSURE INJECTABLE QUAD-LUMEN CVC KIT

Lot or serial number

13F16K0302
13F16L0071
13F16M0048
13F17C0325
13F17D0283
13F17E0124
13F17F0071
13F17F0497
13F17F0748
13F17G0428
13F17H0387

Model or catalog number

CA-42854-P1A
CA-45854-P1A
CDA-42854-P1A
CDA-45854-P1A

Companies
Manufacturer
Arrow International Inc.
2400 Bernville Road
Reading
19605
UNITED STATES

E. PERCUTANEOUS SHEATH INTRODUCER KIT WITH ARROWG+ARD BLUE(R) SHEATH

Lot or serial number

13F16M0122
13F17C0267
13F17E0385
13F17F0071
13F17F0226
13F17G0192
13F17H0407

Model or catalog number

CDA-29803-1A

Companies
Manufacturer
Arrow International Inc.
2400 Bernville Road
Reading
19605
UNITED STATES

F. TWO-LUMEN CENTRAL VENOUS ACCESS KIT

Lot or serial number

13F16L0209
13F17F0437
13F17H0503

Model or catalog number

CDA-21242-1A

Companies
Manufacturer
Arrow International Inc.
2400 Bernville Road
Reading
19605
UNITED STATES

G. ARROWG+ARD BLUE LARGE BORE MULTI-LUMEN CVC KIT

Lot or serial number

13F17F0744

Model or catalog number

CDA-22123-1A

Companies
Manufacturer
Arrow International Inc.
2400 Bernville Road
Reading
19605
UNITED STATES