Arrow International Inc: Medical Device Recall in 2017 - (Recall #: Z-2330-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features 3)Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue Plus (R) Catheter and Sharps Safety Features 4) Multi-Lumen Pressure Injectable Central Venous Catheterization Kit with Blue Flex Tip(R)ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features 5)Pressure Injectable ARROWg+ard Blue Plus (R) Multi-Lumen Central Venous Catheterization Kit 6)AGB+Multi-Lumen Central Venous Catheterization Kit 7) AGB+Pressure Injectable Multi-Lumen CVC Kit The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access. Catheter, Intravascular, Therapeutic, Short Term Less Than 30 days

Product Classification:

Class II

Date Initiated: May 9, 2017

Date Posted: June 21, 2017

Recall Number: Z-2330-2017

Event ID: 77232

Reason for Recall:

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

Status: Terminated

Product Quantity: 27,485 units distributed in U.S., 4,371 units distributed internationally

Code Information:

Material number: ASK-12703-PLV1, ASK-15703-PLV, ASK-15703-PRH, ASK-42703-PRJ, ASK-45703-PRH, ASK-45703-PRWJ1, AK-42703-P1A, AK-45703-P1A, CA-42703-P1A, CA-45703-P1A, CDA-42703-P1A, CDA-42802-P1A, CDA-45703-P1A, Device Listing D040746

Distribution Pattern:

Worldwide Distribution - US (nationwide) and Canada

Voluntary or Mandated:

Voluntary: Firm initiated