Palindrome HSI Chronic Catheters Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units distributed worldwide.
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, and the hazard involves a medical device failing to meet antimicrobial specifications, which poses a risk of harm without reported injuries or fatalities in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm (Item Code: 8888123409) manufactured by Covidien LLC. 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. A total of 72,363 units were distributed in the United States and 24,631 units were distributed internationally to numerous countries including Argentina, Austria, Belgium, Brazil, Canada, and others.
Healthcare providers and patients should check their inventory and records for the specific item code and expiry date. If the product matches the recalled description, it should be removed from use and returned to the manufacturer or supplier according to their instructions.
The recalled product
- Product
- Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409
- 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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