Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0330-2016·Announced 2015-12-02

Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect

Covidien LLC is recalling 160 units of Palindrome Precision Chronic Catheter Kits because they were incorrectly packaged 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 score when no specific injuries or hospitalizations are reported in the source text, fitting the criteria for minor defects or low-risk contamination.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 160 units of the Palindrome Precision Chronic Catheter Kit, manufactured by Covidien LLC. The specific product affected is the Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm, Item Number 8888145017P. The recall is due to a packaging error where the catheters were incorrectly packaged with a 90-degree bend at the distal tip.

The affected lots are 1500600182 and 1423000104. These products were distributed worldwide, including the United States (nationwide), Canada, Belgium, Chile, Panama, Denmark, France, Germany, Netherlands, Spain, Switzerland, and the United Kingdom. The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion, and may be inserted either percutaneously or by cutdown.

Healthcare providers and patients should stop using the affected catheter kits and contact the manufacturer or their supplier for instructions on how to return the product. This recall is classified as Class II because the use of the product could, in some cases, cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product: Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.…
Manufacturer: Covidien LLC
Category: Medical Device — Catheters
Hazard: packaging-defect
Affected units: 160

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 (2)

Lot Numbers: 1500600182
1423000104

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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