Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-1160-2018)

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:

Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.

Product Classification:

Class II

Date Initiated: November 14, 2017

Date Posted: March 28, 2018

Recall Number: Z-1160-2018

Event ID: 79342

Reason for Recall:

Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.

Status: Terminated

Product Quantity: 18,124 total

Code Information:

ASK-29803-SJH 13F16K0136

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated