The Recall Desk
ModerateFDA (Devices)·Z-0329-2016·Announced 2015-12-02

Palindrome Chronic Catheter Kit Recalled for Packaging Defect

Covidien LLC is recalling 280 units of Palindrome Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.

What this means for you

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, and the hazard is a packaging defect (bent tip) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 280 units of the Palindrome Chronic Catheter Kit Symmetrical Tip, manufactured by Covidien LLC. The specific item number is 8888145042, and the affected lots are 1503500094, 1431900098, and 1435800009. The recall was initiated because the catheters were 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 in the United States (nationwide), Canada, Belgium, Chile, Panama, Denmark, France, Germany, the Netherlands, Spain, Switzerland, and the United Kingdom.

Healthcare facilities and consumers should stop using the affected catheters and contact the manufacturer for further instructions or a replacement.

The recalled product

Product
Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by c
Manufacturer
Covidien LLC
Affected units
280

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: 1503500094
  • 1431900098
  • 1435800009

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 →