Agency classClass IIOur severity:Severe FDA (Devices)·Z-2535-2015·Announced 2015-09-09

MAHURKAR Acute Dialysis Catheter Recalled for Potential Sterility Compromise

Covidien LLC is recalling 569 MAHURKAR 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide in the US.

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, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the potential for infection from compromised sterility in an invasive medical device warrants a high severity rating.

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, 16cm, with Curved Extensions, manufactured by Covidien LLC. The recall affects 569 kits with Lot Number 1504700146, which were distributed nationwide in the United States.

The recall was initiated because the sterility of the devices may be compromised. These sterile delivery systems are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

Healthcare facilities and consumers who have these specific products should stop using them immediately and contact the manufacturer or their supplier for instructions on return or replacement.

The recalled product

Product: MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP 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: 569

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: 1504700146

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