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

Neonatal Iv Access Set recalled by Centurion Medical Products

Centurion Medical Products is recalling Neonatal Iv Access Set, 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 codesIV4690 Lot codes: 2015111690 2016012590 2016040490 2016082990 2016111490 2017010990 2017013090 2017052990 2017080790

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-1090-2018
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: Potency & Assay
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 contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

NEONATAL IV ACCESS SET

Where it was distributed

Nationally

Nationwide

Questions about this recall

Is Neonatal Iv Access Set recalled?

Yes. Centurion Medical Products recalled Neonatal Iv Access Set on 23 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-1090-2018.

Why was it recalled?

Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.

Which lots are affected?

IV4690 Lot codes: 2015111690 2016012590 2016040490 2016082990 2016111490 2017010990 2017013090 2017052990 2017080790

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.

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