Agency classClass IIOur severity:High FDA (Devices)·Z-1865-2015·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 72,363 units in the US and 24,631 internationally.

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, which typically corresponds to a 'High' severity score (3) in the absence of reported hospitalizations or injuries, as the hazard is a potential failure to meet antimicrobial specifications rather than a confirmed serious injury event.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Palindrome SI Chronic Catheter Kit with VenaTrac Stylet (14.5 Fr x 33cm, Item Code: 8888145065C) manufactured by Covidien LLC. The recall was initiated because the catheters may not meet the required antimicrobial specifications. This classification indicates 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 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 nationwide distribution in the US and shipments to numerous countries across the Americas, Europe, Asia, Africa, and the Middle East.

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 this recall is a precautionary measure to ensure the product meets safety standards regarding antimicrobial performance.

The recalled product

Product: Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065C
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

See all →

Moderate
EndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
Moderate
Covidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
Moderate
Covidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
Moderate
Covidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
Moderate
Shiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10

Same hazard · infection risk