The Recall Desk
ModerateFDA (Devices)·Z-1869-2015·Announced 2015-07-08

Covidien Recalls Palindrome Precision SI Chronic Catheter Kits

Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

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. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a failure to meet antimicrobial specifications rather than a confirmed high-risk pathogen or structural defect.

Plain-English summary

Covidien LLC is recalling the Palindrome Precision SI Chronic Catheter Kit with VenaTrac Stylet (14.5 Fr x 19cm, Item Code: 8888145062CP). The recall was initiated because the catheters may not meet antimicrobial specifications.

The affected units are identified by item codes with an expiry date of February 2018 and earlier. A total of 72,363 units were distributed in the United States and 24,631 units were distributed internationally to numerous countries including Argentina, Austria, Belgium, Brazil, Canada, and others.

Healthcare providers and consumers should stop using the affected catheter kits and contact the manufacturer for further instructions or a replacement.

The recalled product

Product
Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062CP
Manufacturer
Covidien LLC

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)

  • Item codes identified with an expiry date of February 2018 and earlier

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 62 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 62 products in this recall →