Device product
ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A
Z-1336-2018
Product summary
- Event
- Event 79512
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1336-2018
Official wording
Reason: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Code information: Lot Numbers: (1) 13F16M0268, 13F17C0395, 13F17E0158, 13F17E0536; (2) 13F17A0254; (3) 13F16M0233, 13F17D0190; (4) 13F17B0137, 13F17D0225
Distribution pattern: Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
Derived failure modes
-
Unknown
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.