Agency classClass IIOur severity:High FDA (Devices)·Z-2529-2015·Announced 2015-09-09

Recall of Mahurkar Elite Acute Dual Lumen Catheter Trays Due to Sterility Concerns

Covidien LLC is recalling specific Mahurkar Elite Acute Dual Lumen Catheter Trays because their sterility may be compromised.

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 involves a medical device where sterility may be compromised, posing a risk of harm (infection) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for the Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components, 13.5 Fr x 20 cm. The recall is being conducted by the manufacturer, Covidien LLC. The specific product affected is identified by Item Code 8888213420 and Lot Number 1504000115. The quantity involved in this recall is 4 kits.

The reason for the recall is that the sterility of the medical devices may be compromised. These sterile delivery devices are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices. The products were distributed nationwide in the United States.

Healthcare facilities and consumers who possess these specific catheter trays should stop using them immediately. Users should contact their supplier or the manufacturer for further instructions on how to return or dispose of the affected products.

The recalled product

Product: Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components, 13.5 Fr x 20 cm Item Code: 8888213420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
Manufacturer: Covidien LLC
Category: Medical Device — Catheters
Hazard: sterility-compromise
infection-risk
Affected units: 4

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)

Lot Numbers: 1504000115

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by Covidien LLC 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 13 products in this recall →

Same manufacturer · Covidien LLC

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Same hazard · sterility compromise