Palindrome SI Chronic Catheter Sport Pack Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome SI Chronic Catheter Sport Packs 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
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. Per the rubric, a Class II recall without explicit reports of hospitalization or significant injury falls into the High (3) category, representing a risk of harm where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm, manufactured by Covidien LLC. The recall is due to the possibility that the catheters may not meet antimicrobial specifications. The affected product is identified by item code 8888223408 and has an expiry date of February 2018 or earlier.
The recall covers 72,363 units distributed in the United States and 24,631 units distributed internationally. The product was distributed nationwide in the US and to numerous countries, including 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 or their supplier for instructions on return or replacement. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408
- 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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