Agency classClass IIOur severity:High FDA (Devices)·Z-1635-2024·Announced 2024-05-01

Palindrome Precision H Chronic Catheter Kit may lack labeled heparin coating

Covidien is recalling 878 units of Palindrome Precision H Chronic Catheter Kits that may lack the heparin anticoagulant coating indicated on the label, potentially reducing clot prevention during hemodialysis.

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: FDA Class II recall for medical catheters where the heparin anticoagulant coating may be missing when labeled as present. The source reports no illnesses or injuries, making this a risk-of-harm scenario without reported harm, consistent with a High severity rating.

Plain-English summary

Covidien LP is recalling 878 units of Palindrome Precision H Chronic Catheter Kits (Model 8888145044CP) distributed worldwide, including the United States and multiple countries in Europe and South Africa. The affected lot numbers are 2228000089, 2201700103, and 2228000074.

These catheters are labeled as having a heparin coating, but some units in the recall may not actually contain the heparin coating. The heparin coating is an anticoagulant that prevents blood clots from forming on the catheter. Without this coating, patients lose the intended protective benefit during hemodialysis, apheresis, and infusion procedures.

Patients currently using or scheduled to receive one of these catheters should contact their healthcare provider immediately to determine whether they need to have their catheter inspected or replaced. Do not attempt to remove or replace the catheter yourself—consult with your doctor or the medical facility where you receive treatment.

The recalled product

Product: Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888145044CP
Manufacturer: Covidien LP
Category: Medical Device — Catheter / Hemodialysis
Hazard: mis-labeling
thrombosis-risk
Affected units: 878

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 (4)

GTIN: 20884521158082
10884521158085 Lot Number: 2228000089
2201700103
2228000074

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Covidien LP 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 2 products in this recall →

Same manufacturer · Covidien LP

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