Z-1095-2018Class II

Neonatal IV Start Kit

Name: Z-1095-2018 Neonatal IV Start Kit
Creator: Centurion Medical Products Corporation
Published: 2017-10-23
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2017-10-23 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products Corporation began a recall of NEONATAL IV START KIT on 2017-10-23. FDA classified it as Class II and gives the reason as "Convenience Kit containing components to assist practitioner with IV placement and securement". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1095-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-23
Posted: 2018-03-17
Terminated: 2018-06-21
Recalling firm: Centurion Medical Products, LP
Product: Neonatal IV Start Kit
Product code: LRP Tray, Surgical
Reason for recall: Convenience Kit containing components to assist practitioner with IV placement and securement.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On October 16, 2017 a PRODUCT CORRECTION letter was issued to customers notifying them that if they had any kits in their inventory, Centurion will supply labels to affix to the front of each kit instructing the user to discard the prep pad upon opening the kit. Other components of the kit may continue to be used and are NOT within the scope of this recall.
Distribution: Nationally
Product codes and lots: IVS425 Lot codes: 2016091290 2016082290

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1095-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1078-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1079-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1080-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1081-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1082-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1083-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1084-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1085-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1086-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1087-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1088-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1089-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1090-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1091-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1092-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1093-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1094-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1095-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1096-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1097-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17
Z-1098-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-17

Product code LRP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)