Agency classClass IIOur severity:Severe FDA (Devices)·Z-2533-2015·Announced 2015-09-09

Mahurkar Elite Acute Triple Lumen Catheter Tray Recalled for Sterility Concerns

Covidien LLC is recalling 165 Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised. The affected units were distributed nationwide.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the potential for serious infection from compromised sterility in an invasive medical device aligns with the Severe criteria for Class II recalls.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 165 units of the Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 13 cm (Item Code: 8888233413). The recall is being conducted by the manufacturer, Covidien LLC, due to a potential compromise in the sterility of the devices.

The affected product is identified by Lot Number 1504700136. These sterile delivery devices are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices. The recall covers units that were distributed nationwide in the United States.

Healthcare facilities and consumers should stop using the affected product immediately. Users should contact their supplier or the manufacturer for instructions on how to return the product or obtain a replacement. The FDA classifies this as a Class II recall, meaning the use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 13 cm Item Code: 8888233413 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
Manufacturer: Covidien LLC
Category: Medical Device — Catheter
Hazard: sterility-compromise
infection
Affected units: 165

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: 1504700136

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