Palindrome Precision SI Chronic Catheter Kit Recall for Antimicrobial Failure
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications.
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, and the hazard involves a failure to meet antimicrobial specifications, which poses a risk of harm (infection) even though specific injury reports are not detailed in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Palindrome Precision SI Chronic Catheter Kit with VenaTrac Stylet (14.5 Fr x 28cm, Item Code: 8888145064P). The recall was initiated by the manufacturer, Covidien LLC, 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. The recall covers 72,363 units distributed in the United States and 24,631 units distributed internationally to various countries including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, and others.
Healthcare providers and consumers should stop using the affected catheters and contact the manufacturer or their supplier for instructions on how to return or replace the product.
The recalled product
- Product
- Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064P
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheters
- Hazard
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.
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