Agency classClass IIOur severity:High FDA (Devices)·Z-1095-2018·Announced 2018-03-28

Centurion Medical Recalls Neonatal IV Start Kits Due to Quality Concerns

Centurion Medical Products Corporation is recalling specific lots of Neonatal IV Start Kits. The recall is a Class II action, indicating a potential risk of temporary or medically reversible health consequences.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls without specific reports of hospitalization or significant injury are typically scored as High (3), representing a risk of temporary or medically reversible health consequences.

Plain-English summary

Centurion Medical Products Corporation is voluntarily recalling specific lots of Neonatal IV Start Kits. These kits contain components designed to assist medical practitioners with intravenous (IV) placement and securement for neonatal patients. The affected products are identified by the code IVS425 and lot codes 2016091290 and 2016082290. The products were distributed nationally.

The U.S. Food and Drug Administration (FDA) has classified this recall as Class II. This classification indicates that the use of, or exposure to, the violation is likely to cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. The source text does not specify the exact nature of the defect or the specific reason for the recall beyond the agency's classification.

Healthcare facilities and practitioners who have received these specific lots of Neonatal IV Start Kits should stop using them immediately. They should contact Centurion Medical Products Corporation for instructions on how to return or dispose of the affected products. Consumers are not directly affected as these are professional medical devices intended for use by practitioners.

The recalled product

Product: NEONATAL IV START KIT
Manufacturer: Centurion Medical Products Corporation
Category: Medical Device — IV Supplies
Hazard: quality-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

IVS425 Lot codes: 2016091290 2016082290

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 21 recalled by Centurion Medical Products Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →

Same manufacturer · Centurion Medical Products Corporation

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Same hazard · quality defect