Arrow International Inc: Medical Device Recall in 2014 - (Recall #: Z-1633-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.

Product Classification:

Class II

Date Initiated: July 17, 2013

Date Posted: May 28, 2014

Recall Number: Z-1633-2014

Event ID: 67833

Reason for Recall:

The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and should state, Introducer Needle: 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe. As a result of this labeling inconsistency, if the clinician were to place the needle under x-r

Status: Terminated

Product Quantity: 4285

Code Information:

MF2016829 RM2072044 RM2034076 RM2095792 RM2056629 RM3015571 RM2069733

Distribution Pattern:

US Distribution only to MI.

Voluntary or Mandated:

Voluntary: Firm initiated