The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1092-2018·Announced 2018-03-28

Centurion Medical Recalls Pediatric IV and IV Start Kits

Centurion Medical Products Corporation is recalling Pediatric IV & IV Start Kits. The recall is classified as Class II by the FDA.

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, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. Per the rubric, FDA Class II recalls without specific hospitalization reports or structural defects are typically rated High (3).

Plain-English summary

Centurion Medical Products Corporation is recalling Pediatric IV & IV Start Kits. These convenience kits contain components designed to assist practitioners with IV placement and securement. The recall is classified as Class II by the U.S. Food and Drug Administration.

The source text does not specify the exact reason for the recall, the number of units affected, or any reported injuries or illnesses. The products were distributed nationally.

Consumers and healthcare facilities should check their inventory for the specific lot codes listed in the official recall notice and follow instructions from the manufacturer or the FDA regarding the return or disposal of these kits.

The recalled product

Product
PEDIATRIC IV & IV START KIT

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 hazard · medical device defect

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