Recall of Mahurkar Elite Acute Dual Lumen Catheter Trays Due to Sterility Concerns
Covidien LLC is recalling 116 Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. The affected devices were distributed nationwide in the US.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential sterility compromise in a medical device used for intravascular access, which poses a risk of harm without reported injuries.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 116 units of the Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm (Item Code: 8888211424). The recall was initiated by the manufacturer, Covidien LLC, 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 covers specific lot numbers 1506200114 and 1506900083. These devices were distributed nationwide in the United States.
Healthcare facilities and consumers should stop using the affected catheter trays immediately. Users should contact their supplier or the manufacturer for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: 8888211424 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intrav
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 116
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: 1506200114
- 1506900083
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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