Dialysis Catheters Recalled Due to Missing Heparin Coating
Certain Palindrome Precision HSI dialysis catheters do not have the heparin coating indicated on the label, which could reduce their protective benefits during dialysis procedures.
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 involving a risk-of-harm medical device (dialysis catheter) where the advertised protective heparin coating is missing. No illnesses or injuries have been reported. The missing coating compromises the catheter's labeled anticlotting function.
Plain-English summary
Covidien LP has recalled 305 units of Palindrome Precision HSI Chronic Catheter Sport Pack (Model 8888119369P, Lot 2318500118) because some units may not contain the heparin coating advertised on the product label.
The heparin coating is intended to provide anticlotting protection during hemodialysis, apheresis, and infusion procedures. The absence of this coating represents a loss of the product's labeled protective benefit and could potentially affect catheter performance.
The affected products were distributed worldwide, including throughout the United States and in Austria, Belgium, Canary Islands, Denmark, Faroe Islands, France, Germany, Greece, Iceland, Ireland, Italy, Mayotte, Norway, Poland, Reunion, South Africa, Spain, Sweden, and the United Kingdom.
Patients and healthcare providers with affected catheters should contact Covidien LP for guidance on replacement or alternative products.
The recalled product
- Product
- Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888119369P
- Manufacturer
- Covidien LP
- Affected units
- 305
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)
- GTIN: 20884521157733 Lot Number: 2318500118
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.
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