Devices

Device Recall AGB Multi Lumen CVC Kit

Model / Serial
Lot Numbers: (1) 13F17F0049; (2) 13F17B0224, 13F17E0142, 13F17E0830; (3) 13F16L0220; (4) 13F17E0463, 13F17F0169; (5) 13F17E0685; (6) 13F17D0275, 13F17D0325; (7) 13F17C0470, 13F17D0243; (8) 13F17E0358; (9) 13F17B0031, 13F17E0626; (10) 13F17B0035, 13F17E0627; (11) 13F17B0135, 13F17D0191; (12) 13F16M0173, 13F17C0414
Product Classification
General Hospital and Personal Use 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
AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two-Lumen CVC Kit (8) PN: CDC-45802-1A, (9) PN: CDC-45802-B1A, (10) PN: CDC-46702-1A, (11) CDC-47702-1A; (12) Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features, PN: ASK-45703-AH
Manufacturer
Arrow International Inc
1 Event
- Recall of Device Recall AGB Multi Lumen CVC Kit

Manufacturer

Arrow International Inc

Manufacturer Address
Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA

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