Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
The FDA is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 injuries are not reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for the Palindrome SI Chronic Catheter Kit, Item Code 8888245063, manufactured by Covidien LLC. The recall was initiated because the catheters may not meet antimicrobial specifications. The agency has classified this as a Class II recall.
The recall affects 72,363 units distributed in the United States and 24,631 units distributed internationally. The affected units are identified by an expiry date of February 2018 and earlier. The products were distributed nationwide in the US and to numerous countries worldwide, including Argentina, Austria, Belgium, Brazil, Canada, and the United Kingdom.
Healthcare providers and consumers should stop using the affected catheter kits and contact the manufacturer or their supplier for further instructions. The FDA advises that these devices may not provide the intended antimicrobial protection, which could potentially increase the risk of infection, although specific injury reports are not detailed in the source text.
The recalled product
- Product
- Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063
- 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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