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 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 involves a medical device that may not meet antimicrobial specifications, posing a risk of infection. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Covidien LLC is voluntarily recalling specific lots of the Palindrome SI Chronic Catheter Kit, Item Code 8888245062. The recall is being conducted because the catheters may not meet the required antimicrobial specifications. The product is indicated for acute and chronic hemodialysis, apheresis, and infusion.
The recall covers 72,363 units distributed in the United States and 24,631 units distributed internationally. Affected units are identified by an expiry date of February 2018 and earlier. The product was distributed nationwide in the US and to numerous countries worldwide, including Argentina, Austria, Belgium, Brazil, Canada, and the United Kingdom.
Healthcare providers and patients should stop using the affected catheter kits and contact their supplier or the manufacturer for instructions on replacement or return. No specific instructions for consumer action are provided in the source text beyond the recall notification.
The recalled product
- Product
- Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion.
- 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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