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

Neonatal Iv Start Kit recalled by Centurion Medical Products

Centurion Medical Products is recalling Neonatal Iv Start Kit, distributed nationwide in the US. The recall was initiated on 23 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesIVS425 Lot codes: 2016091290 2016082290

Quantity recalledN/A

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-1095-2018
FDA event ID: 79329
Recalling firm: Centurion Medical Products, Williamston, MI
Classification: Class II
Status: Terminated
Recall initiated: 23 Oct 2017
FDA classified: 17 Mar 2018
Reported: 28 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Oct 2017	Recall initiated by company
17 Mar 2018	Classified by FDA	+145 days
28 Mar 2018	Published in enforcement report	+11 days

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

Reason for recall

Convenience Kit containing components to assist practitioner with IV placement and securement.

Product as listed by the FDA

NEONATAL IV START KIT

Where it was distributed

Nationally

Nationwide

Questions about this recall

Is Neonatal Iv Start Kit recalled?

Yes. Centurion Medical Products recalled Neonatal Iv Start Kit on 23 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-1095-2018.

Why was it recalled?

Convenience Kit containing components to assist practitioner with IV placement and securement.

Which lots are affected?

IVS425 Lot codes: 2016091290 2016082290

Where was it sold?

Nationally

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.

More recalls from Centurion Medical Products

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