Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0332-2016·Announced 2015-12-02

Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect

Covidien LLC is recalling 150 units of Palindrome Precision Chronic Catheter Kits due to incorrect packaging with a 90-degree bend at the distal tip.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level involving temporary or medically reversible adverse health consequences, without reported serious injuries or deaths.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 150 units of the Palindrome Precision Chronic Catheter Kit, manufactured by Covidien LLC. The specific product affected is the Symmetrical Tip, Tal VenaTrac Stylet 14.5 Fr/Ch (4.8mm) X 33 cm, Item Number 8888145046C, Lot Number 1506100125. The recall is due to the product being incorrectly packaged with a 90-degree bend at the distal tip.

The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. 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.

Healthcare providers and patients should stop using the affected catheters and contact the manufacturer or their supplier for further instructions. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse 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: 8888145046C The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either…
Manufacturer: Covidien LLC
Category: Medical Device — Catheters
Hazard: packaging-defect
physical-damage
Affected units: 150

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: 1506100125

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.

See all 5 products in this recall →

Same manufacturer · Covidien LLC

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