Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC 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. The source text does not report any hospitalizations, serious injuries, or deaths, and the hazard is a failure to meet antimicrobial specifications rather than a confirmed high-risk pathogen or structural defect causing harm.
Plain-English summary
Covidien LLC is recalling the Palindrome HSI Chronic Catheter Kit with VenaTrac Stylet (14.5 Fr x 19cm, Item Code: 8888145057C). The recall is being conducted because the catheters may not meet antimicrobial specifications. The affected products are identified by item codes with an expiry date of February 2018 and 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 US and to numerous countries including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, and others. The source text does not report any specific illnesses or injuries associated with this recall.
Healthcare providers and consumers should stop using the affected catheter kits and contact the manufacturer or their supplier for further instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057C
- 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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