Agency classClass IIOur severity:Severe FDA (Devices)·Z-2527-2015·Announced 2015-09-09

Recall of Mahurkar Acute Dual Lumen Catheter Trays Due to Sterility Concerns

Covidien LLC is recalling 8 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.

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, and the rubric specifies that FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the potential for serious harm from a compromised sterile medical device in an intravascular setting aligns with the Severe criteria for Class II recalls.

Plain-English summary

The U.S. Food and Drug Administration has issued a Class II recall for 8 kits of Mahurkar Acute Dual Lumen Catheter Trays, High Flow Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm (Item Code: 8888135139). The product is manufactured by Covidien LLC and was distributed nationwide in the United States. The specific lot number affected is 1506500122.

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 possess these specific items should stop using them immediately and contact the manufacturer or their supplier for instructions on return or replacement.

The recalled product

Product: Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135139 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
Manufacturer: Covidien LLC
Category: Medical Device — Catheters
Hazard: infection
sterility-compromise
Affected units: 8

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: 1506500122

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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