CLASS II Device recall · Reported 28 Mar 2018 · FDA Enforcement Report

Pressure Injectable Multi- Lumen CVC Kit recalled by Arrow International

Arrow International is recalling Pressure Injectable Multi- Lumen CVC Kit, distributed nationwide in the US. The recall was initiated on 14 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCDC-15703-P1A 13F16J0336

Quantity recalled18,124 total

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-1165-2018
FDA event ID: 79342
Recalling firm: Arrow International, Reading, PA
Classification: Class II
Status: Terminated
Recall initiated: 14 Nov 2017
FDA classified: 22 Mar 2018
Reported: 28 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Nov 2017	Recall initiated by company
22 Mar 2018	Classified by FDA	+128 days
28 Mar 2018	Published in enforcement report	+6 days

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

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.

Product as listed by the FDA

Pressure Injectable Multi- Lumen CVC Kit

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is Pressure Injectable Multi- Lumen CVC Kit recalled?

Yes. Arrow International recalled Pressure Injectable Multi- Lumen CVC Kit on 14 Nov 2017. The recall is Class II and its status is Terminated. Recall number Z-1165-2018.

Why was it recalled?

Which lots are affected?

CDC-15703-P1A 13F16J0336

Where was it sold?

Nationwide Distribution

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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