Device product
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer.
Z-2819-2018
Product summary
- Event
- Event 80682
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5507 units
- Official record key
device-enforcement:Z-2819-2018
Official wording
Reason: The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
Code information: 14F15G0105, 14F15H0230, 14F15L0085, 14F16A0438, 14F16C0142, 14F16D0060, 14F16F0046, 14F16F0564
Distribution pattern: Worldwide Distribution: US (nationwide) to the following states of: AK, AL, CA, FL, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NY, OH, OR, PA, SC, SD, TX, WI, and WV; to countries of:: Finland, Germany, Hungary, Netherlands, South Africa, United Arab Emirates and the United Kingdom.
Derived failure modes
-
Labeling or packaging
packaging may not be sealed. If the packaging is compromised
-
Sterility assurance
packaging may not be sealed. If the packaging is compromised in this manner, the sterility