Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
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. The hazard involves a failure to meet antimicrobial specifications, which poses a risk of infection (a high-risk pathogen/injury scenario) without reported fatalities or hospitalizations in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm (Item Code: 8888245064) manufactured by Covidien LLC. The recall is due to the possibility that the catheters may not meet antimicrobial specifications. This defect could potentially increase the risk of infection for patients using the device.
The recall covers 72,363 units distributed in the United States and 24,631 units distributed internationally. The affected products are identified by item codes with an expiry date of February 2018 and earlier. Distribution was worldwide, including the US and numerous countries across Europe, Asia, the Americas, and the Middle East.
Healthcare providers and patients should stop using the affected catheters and contact their supplier or the manufacturer for further instructions. The FDA classifies this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheters
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)
- Item codes identified with an expiry date of February 2018 and earlier
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 62 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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