Covidien Recalls Palindrome Precision SI Chronic Catheter Kits for Antimicrobial Defects
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 units internationally.
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 3/5 (High).
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. The hazard involves a failure to meet antimicrobial specifications, which poses a risk of harm (infection) but the source text does not report any specific illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.
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, 14.5 Fr x 55cm, manufactured by Covidien LLC. The recall is due to the possibility that the catheters may not meet antimicrobial specifications. The affected product is identified by item code 8888145066CP 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. The products were distributed nationwide in the US and to numerous countries including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, and others. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the affected catheter kits and contact their supplier or the manufacturer for instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheters
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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