Palindrome SI Chronic Catheter Recall for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome SI Chronic Catheters 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
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 without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Covidien LLC is recalling the Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm (Item Code: 8888128458). The recall is being conducted because the catheters may not meet antimicrobial specifications. This is an FDA Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
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 distribution was worldwide, including countries such as Argentina, Austria, Belgium, Brazil, Canada, and the United Kingdom.
Consumers and healthcare providers should stop using the affected catheters and contact their supplier or the manufacturer for further instructions. The recall is voluntary and is intended to ensure that only compliant medical devices are used in clinical settings.
The recalled product
- Product
- Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
- 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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