Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source explicitly identifies this as an FDA Class II recall. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving medical devices where failure to meet specifications could lead to adverse health consequences.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm (Item Code: 8888145049) manufactured by Covidien LLC. The recall is due to the possibility that 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 to numerous countries, including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, and others.
Healthcare providers and patients should contact their healthcare provider or the manufacturer for further instructions regarding the use of these devices. The FDA classifies this as a Class II recall, indicating that 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.
The recalled product
- Product
- Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049
- 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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