Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
FDA Class II recall of Palindrome SI Chronic Catheter Kits by Covidien LLC because the devices may not meet antimicrobial specifications.
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. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or significant injury are typically scored as High (3), representing a risk of harm 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 Palindrome SI Chronic Catheter Kits, Item Code 8888245064, manufactured by Covidien LLC. The recall was initiated because the catheters may not meet the required antimicrobial specifications.
The affected units are identified by item codes with an expiry date of February 2018 and earlier. A total of 72,363 units were distributed in the United States and 24,631 units were distributed internationally to numerous countries, including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, and others.
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, meaning the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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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