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Devices
Device Recall Access Tray
Model / Serial
Lot Numbers: (1) 13F17E0546; (2) 13F16L0177, 13F17E0449, 13F17E0873, 13F17F0295; (3) 13F17E0677, 13F17F0477; (4) 13F17A0318, 13F17F0083; (5) 13F16M0272, 13F17E0648; (6) 13F17B0122, 13F17F0512; (7) 13F17A0320, 13F17F0528
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
Product Description
(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A
Manufacturer
Arrow International Inc
1 Event
Recall of Device Recall Access Tray
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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
Language
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