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 units distributed worldwide with expiry dates of February 2018 and earlier.
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 failure to meet antimicrobial specifications, which poses a risk of harm (infection) even though specific injury reports are not detailed in the provided text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported or is theoretical.
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 was initiated because the catheters may not meet the required antimicrobial specifications. This defect could potentially increase the risk of infection for patients using the devices.
The recall affects 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 United States and numerous international markets such as Canada, the United Kingdom, Germany, and Brazil.
Healthcare providers and patients should stop using the affected catheters immediately. Users should contact their healthcare provider for guidance on alternative treatment options. 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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