Agency classClass IIOur severity:Severe FDA (Devices)·Z-2536-2015·Announced 2015-09-09

MAHURKAR Acute Dialysis Catheters Recalled for Potential Sterility Compromise

FDA is recalling MAHURKAR 12Fr Acute Dialysis Catheters due to a potential compromise in sterility.

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 recall is classified as FDA Class II. Per the rubric, an FDA Class II recall involving a medical device with a potential sterility compromise (which implies a risk of infection) is categorized as Severe (Score 4), particularly given the invasive nature of the device.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheters, 20cm, with Curved Extensions, PASS Tray. The recall is being conducted by the manufacturer, Covidien LLC.

The recall is due to a potential compromise in the sterility of the devices. The affected product is indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

The recall involves 325 kits distributed nationwide in the United States. The specific lot numbers affected are 1508900109 and 1507600095. Users should stop using these devices and contact the manufacturer for further instructions.

The recalled product

Product: MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access…
Manufacturer: Covidien LLC
Category: Medical Device — Dialysis Catheter
Hazard: sterility-compromise
infection-risk
Affected units: 325

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 (2)

Lot Numbers: 1508900109
1507600095

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