Agency classClass IIOur severity:High FDA (Devices)·Z-2532-2015·Announced 2015-09-09

Mahurkar Elite Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns

The FDA is recalling Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. This Class II recall affects a specific lot 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 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 potential sterility compromise in a medical device, which poses a risk of harm (infection) even though specific injury reports are not detailed in the provided text.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling the Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 20 cm (Item Code: 8888222420). The recall is being conducted by the manufacturer, Covidien LLC, due to a potential compromise in the product's sterility.

The affected product is a sterile delivery system indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices. The recall covers Lot Number 1505400155, which was distributed nationwide in the United States. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and facilities should check their inventory for the specific lot number listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients who have received this specific product should contact their healthcare provider for further evaluation.

The recalled product

Product: Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code: 8888222420 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-risk
Affected units: 1

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: 1505400155

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