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