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Devices
Arrow
Model / Serial
Product No. AP-06018. Lot Numbers: MF2071557, MF2081915, MF2112752, MF3013138, MF3013309, MF3043927, MF3054236, MF3054472, MF3054594, MF3074941, MF3075061, MF3085480, MF3095763, MF3116074, MF3116187, MF4016702, MF4016725, MF4020805, MF4031013, MF4031188, MF4031373, MF4052203, MF4063052, MF4073779, MF4073837, MF4094885, MF4105259, MF4105799, MF4126881, MF5017404, MF5028031, MF5038301, MF5038425, MF5038760, MF5049322, MF5059729, MF5059889, MF5060171, MF5081718, MF5103002, MF5103502, MF5113789, MF5113991, MF6014861, MF6014998, MF6036561, MF6036618, MF6058293, MF6058347, MF6068925.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide. The firm is NOT recalling from international accounts.
Product Description
Implantable Vascular Access system --Infusion Ports with Silicone Rubber Catheter. || Latex-free A Port. 9 Fr. Introducer Kit. || Ref. Product No. AP-06018.
Manufacturer
Arrow International Inc
1 Event
Recall of Arrow
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Manufacturer
Arrow International Inc
Manufacturer Address
Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA
570 devices with a similar name
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Device Recall Arrow Percutaneous Sheath Introducers
Model / Serial
All lots of Product codes listed in Z-1489-2009.
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Singapore, Slovakia, South Africa, South Korea, Spain, Sri lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, and Venezuela.
Product Description
Arrow Percutaneous Sheath Introducers
Manufacturer
Arrow International Inc
Device Recall Arrow Single Lumen CVCs
Model / Serial
All lots of Product codes listed in Z-1489-2009.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Singapore, Slovakia, South Africa, South Korea, Spain, Sri lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, and Venezuela.
Product Description
Arrow Single Lumen CVCs (Central Venous Catheters)
Manufacturer
Arrow International Inc
Device Recall Arrow MultiLumen CVC w/ BlueFlex Tip
Model / Serial
All lots of Product codes listed in Z-1489-2009.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Singapore, Slovakia, South Africa, South Korea, Spain, Sri lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, and Venezuela.
Product Description
Arrow Multi-Lumen CVC w/ BlueFlex Tip (Central Venous Catheter)
Manufacturer
Arrow International Inc
Device Recall Arrow TwoLumen Central Venous Access (MAC)
Model / Serial
All lots of Product codes listed in Z-1489-2009.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Singapore, Slovakia, South Africa, South Korea, Spain, Sri lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, and Venezuela.
Product Description
Arrow Two-Lumen Central Venous Access (MAC)
Manufacturer
Arrow International Inc
Device Recall Arrow ARROWgard QuadLumen CVCs
Model / Serial
All lots of Product codes listed in Z-1489-2009.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Singapore, Slovakia, South Africa, South Korea, Spain, Sri lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, and Venezuela.
Product Description
Arrow ARROWg+ard Quad-Lumen CVCs (Central Venous Catheters)
Manufacturer
Arrow International Inc
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