Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
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) in the absence of reported hospitalizations or injuries, as the hazard is a potential failure to meet antimicrobial specifications rather than a confirmed serious injury event.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Palindrome SI Chronic Catheter Kit with VenaTrac Stylet (14.5 Fr x 33cm, Item Code: 8888145065C) manufactured by Covidien LLC. The recall was initiated because the catheters may not meet the required antimicrobial specifications. This classification indicates 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.
The recall involves 72,363 units distributed in the United States and 24,631 units distributed internationally. The affected products are identified by item codes with an expiry date of February 2018 and earlier. Distribution was worldwide, including nationwide distribution in the US and shipments to numerous countries across the Americas, Europe, Asia, Africa, and the Middle East.
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 safety standards regarding antimicrobial performance.
The recalled product
- Product
- Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065C
- 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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