FDA Recalls Palindrome Precision Chronic Catheters for Antimicrobial Specification Failure
FDA is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
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 FDA classifies this as a Class II recall, and the hazard involves a medical device failing to meet antimicrobial specifications, which poses a risk of harm without reported injuries or fatalities in the source text.
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 23cm (Item Code: 8888123408P) manufactured by Covidien LLC. The recall is due to the possibility that 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 are identified by item codes with an expiry date of February 2018 and earlier. Distribution was worldwide, including the US and numerous international locations.
Healthcare providers and consumers should stop using the affected catheters and contact their supplier or the manufacturer for instructions on return or replacement. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123408P
- 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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