Skip to content
Recall Observatory FDA recall evidence

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

July 10, 2018

Class II

Product summary

Firm
Arrow International Inc
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

    reason.labeling_packaging · v1.0.0

    packaging may not be sealed. If the packaging is compromised
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    packaging may not be sealed. If the packaging is compromised in this manner, the sterility