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-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer.
Z-2818-2018
Product summary
- Event
- Event 80682
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7024 units
- Official record key
device-enforcement:Z-2818-2018
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: 14F15F0156, 14F15H0228, 14F15K0746, 14F16B0085, 14F16D0424, 14F16F0700, 14F16G0471
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