Agency classClass IIOur severity:High FDA (Devices)·Z-1866-2015·Announced 2015-07-08

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 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

Covidien LLC is voluntarily recalling the Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm (Item Code: 8888145066). The recall is being conducted because the catheters may not meet the required antimicrobial specifications. This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recall involves 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.

Healthcare providers and patients should stop using the affected catheters and contact their supplier or the manufacturer for instructions on return or replacement. Consumers should verify the item code and expiry date on their packaging to determine if they are affected.

The recalled product

Product: Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066
Manufacturer: Covidien LLC
Category: Medical Device — Catheters
Hazard: infection-risk
specification-failure

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.

See all 62 products in this recall →

Same manufacturer · Covidien LLC

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