Mahurkar Elite Acute Triple Lumen Catheter Tray Recalled for Sterility Concerns
Covidien LLC is recalling 171 kits of Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised.
What this means for you
Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by compromised sterility in an invasive device) fall under the 'Severe' category.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 171 kits of Mahurkar Elite Acute Triple Lumen Catheter Trays, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm (Item Code: 8888233420). The recall is being conducted by the manufacturer, Covidien LLC.
The reason for the recall is that 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. The affected product is identified by Lot Number 1504700138.
The product was distributed nationwide in the United States. The source text does not specify the number of reported illnesses or injuries associated with this recall. Healthcare facilities and consumers should stop using the affected product and contact the manufacturer or the FDA for further instructions.
The recalled product
- Product
- Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm Item Code: 8888233420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular ac
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheters
- Affected units
- 171
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: 1504700138
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.
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