Palindrome HSI Chronic Catheters Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units 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 FDA classifies this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when associated with potential adverse health consequences such as failure to meet antimicrobial specifications.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm (Item Code: 8888119369) manufactured by Covidien LLC. The recall was initiated 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 including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, and others. The FDA classifies this as a Class II recall, indicating a situation where 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 patients should stop using the affected catheters and contact the manufacturer or their supplier for instructions on return or replacement. Consumers should verify the item code and expiry date of their devices to determine if they are affected by this recall.
The recalled product
- Product
- Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369
- 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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