Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
The FDA is recalling Palindrome HSI 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
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential failure to meet antimicrobial specifications, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary recalls without reported harm.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Palindrome HSI Chronic Catheter Kits with VenaTrac Stylet (14.5 Fr x 19cm, Item Code: 8888145048) 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 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 affects 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 international locations such as Argentina, Austria, Belgium, Brazil, Canada, and the United Kingdom.
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 product quality and safety standards are met.
The recalled product
- Product
- Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145048
- 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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