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Devices
Device Recall Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Cat
Model / Serial
Lot numbers RF0018145, RF0021641, RF9044164, RF9069739, RF9070837, RF9100262
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
All affected product was distributed to one foreign consignee: Arrow Japan Ltd.
Product Description
Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801
Manufacturer
Arrow International Inc
1 Event
Recall of Device Recall Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Cat
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Manufacturer
Arrow International Inc
Manufacturer Address
Arrow International Inc, 2400 Bernville Road, Reading PA 19605
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA
Language
English
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