FDA Recalls Palindrome SI Chronic Catheter Kits for Antimicrobial Specification Failure
The FDA 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
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, FDA Class II recalls without specific hospitalization reports or structural defects fall into the High severity 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 Palindrome SI Chronic Catheter Kits with VenaTrac Stylet (14.5 Fr x 28cm), 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 8888145064C and has an expiry date of February 2018 or 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 various countries including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, and others. The agency classifies this as a Class II recall, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and consumers should stop using the affected catheters and contact their supplier or the manufacturer 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 Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C
- 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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