FDA Recalls Palindrome Precision Chronic Catheters for Antimicrobial Specification Failure
The FDA is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device that may not meet antimicrobial specifications, posing a risk of harm (infection) without reported illnesses or injuries, which 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) is recalling Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm (Item Code: 8888133508P) manufactured by Covidien LLC. The recall was initiated because the catheters may not meet antimicrobial specifications.
The recall includes 72,363 units distributed in the United States and 24,631 units distributed internationally. The affected products have item codes identified with an expiry date of February 2018 and earlier. Distribution was worldwide, including the United States and numerous international markets such as Argentina, Austria, Belgium, Brazil, Canada, and the United Kingdom.
Healthcare providers and consumers should stop using the affected catheters and contact their supplier or the manufacturer for further instructions on return or replacement.
The recalled product
- Product
- Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P
- 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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