Recall of Palindrome Precision SI Chronic Catheters Due to Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall covers 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 or significant safety concerns, even if specific hospitalization reports are not detailed in the brief source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm, manufactured by Covidien LLC. The recall is being conducted because the catheters may not meet antimicrobial specifications. The affected product is identified by item code 8888133508P with an expiry date of February 2018 and earlier.
The recall involves 72,363 units distributed in the United States and 24,631 units distributed internationally. The product was 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, 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 consumers should stop using the affected catheters and contact the manufacturer for further instructions or a replacement. This recall is a precautionary measure to ensure that all devices meet the required antimicrobial standards for patient safety.
The recalled product
- Product
- Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheter
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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