Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC 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, 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 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 the Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm (Item Code: 8888146144CP) manufactured by Covidien LLC. The recall is being conducted because the catheters may not meet antimicrobial specifications. This is a Class II recall, which the FDA defines as a situation where 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.
The recall affects 72,363 units distributed in the United States and 24,631 units distributed internationally. The affected units are identified by an expiry date of February 2018 and earlier. The product was distributed nationwide in the US 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 the manufacturer or their supplier for further instructions. The FDA advises that this recall is a precautionary measure to ensure the product meets required safety standards.
The recalled product
- Product
- Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144CP
- 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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