Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Specification
The FDA is recalling Palindrome Precision 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, and the hazard involves a medical device failing to meet antimicrobial specifications, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Palindrome Precision SI Chronic Catheter Kits, Item Code 8888146144P, manufactured by Covidien LLC. The recall is being conducted because the catheters may not meet antimicrobial specifications. This is classified 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.
The affected products are identified by item codes with an expiry date of February 2018 and earlier. The recall involves 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 numerous countries worldwide, including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, and others.
Healthcare providers and consumers should stop using the affected catheter kits and contact their supplier or the manufacturer for further instructions. The FDA advises that the antimicrobial coating on these devices may not be effective as intended, which could potentially impact the device's ability to prevent infection, although no specific injuries or illnesses have been reported in the source text.
The recalled product
- Product
- Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144P
- 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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