Agency classClass IIOur severity:High FDA (Devices)·Z-0078-2020·Announced 2019-10-16

Centurion Neonatal Procedure Tray Recall Due to Connector Fluid Droplet Risk

Centurion Medical Products is recalling Neonatal Procedure Tray PICC Catheters because the included BD MaxZeroNeedleess Connector may release fluid droplets when disconnected.

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 and involves a risk of fluid droplet separation from a medical device, which poses a potential for harm but does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I).

Plain-English summary

Centurion Medical Products Corporation is recalling Neonatal Procedure Tray PICC Catheters (CVI4535). The recall involves 181,965 units that were distributed nationwide in the United States. The product code is 2019020190.

The recall is necessary because the kits include the BD MaxZeroNeedleess Connector, which was previously recalled by its manufacturer. The connector has a potential for droplets of fluid to separate from the sealed surface following disconnection.

This recall is classified as Class II by the FDA. Consumers and healthcare facilities should stop using the affected kits and contact the manufacturer for instructions on return or replacement.

The recalled product

Product: NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535
Manufacturer: Centurion Medical Products Corporation
Category: Medical Device — Catheters
Hazard: fluid-contamination
device-defect
Affected units: 181,965

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)

2019020190

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 33 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 33 products in this recall →

Same manufacturer · Centurion Medical Products Corporation

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Same hazard · fluid contamination