Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-2819-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 10, 2018

Date Posted: August 22, 2018

Recall Number: Z-2819-2018

Event ID: 80682

Reason for Recall:

The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.

Status: Terminated

Product Quantity: 5507 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated