Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as they may cause temporary or medically reversible adverse health consequences.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm (Item Code: 8888145066C) 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. 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 various countries in Europe, Asia, the Americas, and the Middle East.
Healthcare providers and consumers 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, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C
- 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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