Mahurkar Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns
Covidien LLC is recalling 96 kits of Mahurkar Acute Dual 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, and the hazard involves compromised sterility in a medical device, which poses a significant risk of infection or serious injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 96 kits of Mahurkar Acute Dual Lumen Catheter Trays, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm. The product is manufactured by Covidien LLC and is indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
The recall is being conducted because the sterility of the product may be compromised. The affected lot number is 1508200108. The product was distributed nationwide in the United States.
Healthcare providers and facilities should stop using the affected product immediately. Consumers should not use the product and should contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135137 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascul
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheter
- Affected units
- 96
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: 1508200108
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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