Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect
Covidien LLC is recalling 365 units of Palindrome Precision Chronic Catheter Kits because they were incorrectly packaged 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. According to the rubric, FDA Class II recalls without specific reports of hospitalization or significant injury are typically scored as High (3), representing a risk of harm where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 365 units of the Palindrome Precision Chronic Catheter Kit Symmetrical Tip, manufactured by Covidien LLC. The affected product is intended for acute and chronic hemodialysis, apheresis, and infusion. The recall was initiated because the catheters were incorrectly packaged with a 90-degree bend at the distal tip.
The affected lots are 1504700102, 1516900090, and 1425000091. The product was distributed worldwide, including the United States (nationwide), Canada, Belgium, Chile, Panama, Denmark, France, Germany, the Netherlands, Spain, Switzerland, and the United Kingdom.
Healthcare providers and patients should stop using the affected catheters and contact the manufacturer or their supplier for instructions on return or replacement. The FDA classifies this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneousl
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheter
- Affected units
- 365
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 (3)
- Lot Numbers: 1504700102
- 1516900090
- 1425000091
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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