Agency classClass IIOur severity:Severe FDA (Devices)·Z-2537-2015·Announced 2015-09-09

Recall of Mahurkar Acute Dialysis Catheters Due to Sterility Concerns

Covidien LLC is recalling 550 kits of Mahurkar 12Fr Acute Dialysis Catheters because sterility may be compromised. The products 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 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 Severe. While specific injury reports are not detailed in the provided text, the agency's Class II classification for a sterile medical device where sterility is compromised aligns with the Severe criteria for significant risk.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 550 kits of Mahurkar 12Fr High Pressure Triple Lumen Acute Dialysis Catheters, 20cm, Straight Extensions, PASS Tray (Item Code: 8888104003HP). The recall is being conducted by the manufacturer, Covidien LLC, because the sterility of the devices may be compromised.

The affected products are identified by Lot Numbers 1504700147 and 1507600096. These sterile delivery catheters are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices. The recall covers products distributed nationwide in the United States.

Healthcare facilities and distributors should stop using the affected lots immediately. Users should contact the manufacturer for further instructions on how to return or dispose of the recalled products.

The recalled product

Product: MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item Code: 8888104003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
Manufacturer: Covidien LLC
Category: Medical Device — Dialysis Catheter
Hazard: sterility-compromise
infection
Affected units: 550

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: 1504700147
1507600096

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