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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