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Health product recall

Arrow Catheter Kits (2017-05-15)

Starting date:
May 15, 2017
Posting date:
June 7, 2017
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-63534

Affected Products

A. Arrow-Howes Multi-Lumen Central Venous Catheterization Set
B. Pressure Injectable Picc Kit
C. Arrowg+Ard Blue Plus Central Venous Catheter Kits
D. Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheterization Set
E. Agb+ Pressure Injectable Quad-Lumen Cvc Kit
F. Percutaneous Sheath Introducer Set With Arrowg+Ard Blue Sheath
G. Mac Two-Lumen Central Venous Access Kit With Arrowg+Ard Blue Access Device
H. Arrowg+Ard Hemodyalysis Catheter Sets/Kits

Reason

Arrow International is recalling the 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.

Affected products

A. Arrow-Howes Multi-Lumen Central Venous Catheterization Set

Lot or serial number

13F16G0127

Model or catalog number

ASK-12703-PRJ

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

B. Pressure Injectable Picc Kit

Lot or serial number

13F16H0352
13F16J0124
13F16K0297

Model or catalog number

EU-04041-HPMSB
EU-05041-HPMSB
EU-05052-HPMSB

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

C. Arrowg+Ard Blue Plus Central Venous Catheter Kits

Lot or serial number

13F16L0007
13F16M0013

Model or catalog number

ASK-42703-PRJ

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

D. Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheterization Set

Lot or serial number

13F16G0238
13F16H0093
13F16J0016
13F16K0239
13F16K0306
13F16L0091
13F16L0285
13F16M0047

Model or catalog number

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

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

E. Agb+ Pressure Injectable Quad-Lumen Cvc Kit

Lot or serial number

13F16H0153

Model or catalog number

ASK-42854-PRJ

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

F. Percutaneous Sheath Introducer Set With Arrowg+Ard Blue Sheath

Lot or serial number

13F16M0122

Model or catalog number

CDA-29803-1A

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

G. Mac Two-Lumen Central Venous Access Kit With Arrowg+Ard Blue Access Device

Lot or serial number

13F16L0209

Model or catalog number

CDA-21242-1A

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

H. Arrowg+Ard Hemodyalysis Catheter Sets/Kits

Lot or serial number

13F16L0048

Model or catalog number

CDA-22122-U1A

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