Arrow International Inc: Medical Device Recall in 2015 - (Recall #: Z-1005-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patients vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials. PSI Kit: A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Product Classification:

Class II

Date Initiated: December 16, 2014

Date Posted: January 28, 2015

Recall Number: Z-1005-2015

Event ID: 70017

Reason for Recall:

the Instructions for Use (IFU) were inadvertently removed from the kit.

Status: Terminated

Product Quantity: 420

Code Information:

Multi-Lumen PI CVC Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015 PSI Kit: 8.5 FR X 4-1/8 (10 CM), product code ASK-09803-OSU2 , lot #23F14C1014, exp. 31-Aug-2015:

Distribution Pattern:

In the state of KY

Voluntary or Mandated:

Voluntary: Firm initiated