FDA Recalls Palindrome SI Chronic Catheter Kits for Antimicrobial Defects
The FDA is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
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, which typically corresponds to a High severity score (3) when no specific hospitalizations or serious injuries are reported in the source text. The hazard involves a potential failure to meet antimicrobial specifications, which poses a risk of harm but is not classified as Class I (Critical) or associated with reported fatalities.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Palindrome SI Chronic Catheter Kits with VenaTrac Stylet (14.5 Fr x 23cm), 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 8888145063 and has an expiry date of February 2018 or 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 U.S. and to various countries including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, and others. The FDA classifies this as a Class II recall, which means the 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.
Healthcare providers and consumers should stop using the affected catheter kits and contact the manufacturer or their supplier for further instructions. The recall is voluntary and initiated by the firm to address the potential non-compliance with antimicrobial standards.
The recalled product
- Product
- Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063
- 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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