CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report

Pressure Injectable Multi-Lumen Central Venous recalled

Arrow International is recalling Pressure Injectable Multi-Lumen Central Venous Catheterization Kit Pressure Injectable, distributed nationwide in the US. The recall was initiated on 9 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMaterial 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
Quantity recalled27,485 units distributed in U.S., 4,371 units distributed internationally

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2330-2017
FDA event ID
77232
Recalling firm
Arrow International, Reading, PA
Classification
Class II
Status
Terminated
Recall initiated
9 May 2017
FDA classified
12 Jun 2017
Reported
21 Jun 2017
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

9 May 2017Recall initiated by company
12 Jun 2017Classified by FDA+34 days
21 Jun 2017Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution - US (nationwide) and Canada

Nationwide

Questions about this recall

Is Pressure Injectable Multi-Lumen Central Venous Catheterization Kit Pressure Injectable recalled?

Yes. Arrow International recalled Pressure Injectable Multi-Lumen Central Venous Catheterization Kit Pressure Injectable on 9 May 2017. The recall is Class II and its status is Terminated. Recall number Z-2330-2017.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Worldwide Distribution - US (nationwide) and Canada

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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