Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect
Covidien LLC is recalling 10 units of Palindrome Precision Chronic Catheter Kits due to incorrect packaging with a 90-degree bend at the distal tip.
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: The recall is classified as FDA Class II, which indicates a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences. The defect involves a physical bend in a medical device used for vascular access, posing a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 10 units of the Palindrome Precision Chronic Catheter Kit, manufactured by Covidien LLC. The specific product affected is the Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac Stylet 14.5 Fr/Ch (4.8mm) X 33 cm, Item Number 8888145061P, Lot Number 1425000092.
The recall was initiated because the catheters were incorrectly packaged with a 90-degree bend at the distal tip. This defect could potentially affect the function or safety of the device during insertion or use. The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion.
The affected units were distributed worldwide, including the United States (nationwide), Canada, Belgium, Chile, Panama, Denmark, France, Germany, Netherlands, Spain, Switzerland, and the United Kingdom. Users of these devices should stop using the affected catheters and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheters
- Affected units
- 10
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)
- Lot Numbers: 1425000092
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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.
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