Covidien Recalls Palindrome Precision SI Chronic Catheters for Antimicrobial Issues
Covidien LLC 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 recall is classified as FDA Class II, and the hazard involves a medical device that may not meet antimicrobial specifications, posing a risk of harm without reported injuries.
Plain-English summary
Covidien LLC is recalling specific lots of the Palindrome Precision SI Chronic Catheter Sport Pack with VenaTrac Stylet (14.5 Fr x 28cm). The recall is being conducted because the catheters may not meet antimicrobial specifications. The affected item code is 8888128458P, and the recall includes items 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. The products were distributed nationwide in the US and to numerous countries, including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, and others. The agency has classified this as a Class II recall.
Consumers and healthcare providers should stop using the affected catheters and contact the manufacturer for further instructions. The recall is voluntary and is being conducted to ensure product safety and compliance with specifications.
The recalled product
- Product
- Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458P
- 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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