Device product
Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: " Lack of usable peripheral IV sites " Central venous pressure monitoring " Total parenteral nutrition (TPN) " Infusions of fluids, medications, or chemotherapy " Frequent blood sampling or receiving blood transfusions/blood products
Z-0723-2019
Product summary
- Event
- Event 81665
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 in the US
- Official record key
device-enforcement:Z-0723-2019
Official wording
Reason: The lidstock states the incorrect priming volume and flow rates.
Code information: Lots 14F18F0336 & 14F18E0121
Distribution pattern: Worldwide distribution: US (nationwide) distribution to state of: FL and to countries of: Argentina, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Ecuador, and Peru.
Derived failure modes
-
Unknown
The lidstock states the incorrect priming volume and flow rates.