Palindrome Precision HSI Chronic Catheter Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential failure to meet antimicrobial specifications, which fits the criteria for a moderate severity score in the absence of reported adverse health consequences.
Plain-English summary
Covidien LLC is recalling the Palindrome Precision HSI Chronic Catheter Sport Pack with VenaTrac Stylet (14.5 Fr x 28cm, Item Code: 8888128459P). The recall is being conducted because the catheters may not meet antimicrobial specifications.
The affected units 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. Distribution was worldwide, including the US (nationwide) and countries such as Argentina, Austria, Belgium, Brazil, Canada, Chile, China, and the United Kingdom.
Consumers and healthcare providers should stop using the affected catheters and contact the manufacturer for further instructions.
The recalled product
- Product
- Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459P
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheters
- Hazard
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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