The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1096-2018·Announced 2018-03-28

Centurion Medical Products Recalls Excision Trays for IV Placement

Centurion Medical Products is recalling Excision Trays used for IV placement and securement. 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 typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source does not report specific injuries, placing it in the High severity category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Centurion Medical Products Corporation is recalling Excision Trays, which are convenience kits containing components to assist practitioners with IV placement and securement. The affected products were distributed nationally.

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 or report any specific injuries or illnesses associated with the use of these devices.

Healthcare providers and consumers should stop using the affected Excision Trays. The specific lot codes associated with this recall are 2016010490, 2016033190, 2016082990, 2016120590, 2017042090, and 2017090490.

The recalled product

Product
EXCISION TRAY

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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