Palindrome SI Chronic Catheter Sport Pack Recalled for Antimicrobial Defect
Covidien LLC is recalling Palindrome SI Chronic Catheter Sport Packs because they may not meet antimicrobial specifications.
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 failure to meet antimicrobial specifications, which poses a risk of harm (infection) even though no specific injuries are reported in the text. This aligns with the 'High' severity criteria for risk-of-harm products 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 28 cm (Item Code: 8888228458) manufactured by Covidien LLC. The recall was initiated 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 U.S. (nationwide) and numerous countries across the Americas, Europe, Asia, Africa, and the Middle East.
Consumers and healthcare providers should stop using the affected catheters and contact the manufacturer or their supplier for instructions on return or replacement. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458
- 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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