Palindrome Precision HSI Chronic Catheter Kit Recalled for Antimicrobial Defect
Covidien LLC is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications.
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 failure to meet antimicrobial specifications, which poses a risk of harm (infection) even though specific injuries are not reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm (Item Code: 8888145049CP). The recall is being conducted by the manufacturer, Covidien LLC, because the catheters may not meet antimicrobial specifications.
The affected products are identified by item codes with an expiry date of February 2018 and earlier. A total of 72,363 units were distributed in the United States and 24,631 units were distributed internationally. The products were distributed nationwide in the U.S. and to numerous countries worldwide, including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, and others.
Healthcare providers and consumers should stop using the affected catheter kits and contact the manufacturer or their supplier for further instructions. This recall is classified as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049CP
- 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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