FDA Recalls Palindrome Precision SI Chronic Catheter Kits for Antimicrobial Defects
The FDA is recalling Palindrome Precision 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, and the hazard involves a medical device that may not meet antimicrobial specifications, posing a risk of harm without reported injuries or fatalities, 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) has issued a Class II recall for Palindrome Precision SI Chronic Catheter Kits with VenaTrac Stylet (14.5 Fr x 33cm, Item Code: 8888145065P) manufactured by Covidien LLC. The recall is being conducted because the catheters may not meet antimicrobial specifications. The affected units are identified by 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 worldwide, including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, and others. The FDA 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 facilities should stop using the affected catheter kits and contact the manufacturer for instructions on return or replacement. Consumers who have purchased these products should contact their healthcare provider for guidance.
The recalled product
- Product
- Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065P
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheters
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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