Agency classClass IIOur severity:High FDA (Devices)·Z-1898-2015·Announced 2015-07-08

Palindrome Precision HSI Chronic Catheter Kit Recalled for Antimicrobial Failure

Covidien LLC is recalling specific lots of Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications.

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. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or serious 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 the Palindrome Precision HSI Chronic Catheter Kit with VenaTrac Stylet (14.5 Fr x 23cm, Item Code: 8888145048P) manufactured by Covidien LLC. The recall affects 72,363 units distributed in the United States and 24,631 units distributed internationally. The specific units involved are identified by item codes with an expiry date of February 2018 or earlier.

The reason for the recall is that the catheters may not meet antimicrobial specifications. This deviation from the required antimicrobial standards could potentially increase the risk of infection for patients using the device. The recall is classified as Class II, indicating that 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 affected products were distributed worldwide, including nationwide in the United States and to numerous international markets such as Argentina, Austria, Belgium, Brazil, Canada, Chile, China, and others. Healthcare providers and facilities that have received these specific catheter kits should stop using them and contact the manufacturer for further instructions on return or replacement.

The recalled product

Product: Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048P
Manufacturer: Covidien LLC
Category: Medical Device — Catheter
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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