Palindrome HSI Chronic Catheter Recall for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome HSI Chronic Catheters 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, fitting the criteria for a moderate severity score.
Plain-English summary
Covidien LLC is recalling the Palindrome HSI Chronic Catheter Sport Pack with VenaTrac Stylet (14.5 Fr x 33cm, Item Code: 8888133509). The recall is being conducted because the catheters may not meet antimicrobial specifications. The affected units are identified by an expiry date of February 2018 and earlier.
The recall involves 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.
Healthcare providers and patients should stop using the affected catheters and contact the manufacturer or their supplier for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheter
- 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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