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.
What this means for you
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
- Hazard
- mis-labeling
- thrombosis-risk
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.
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