Palindrome HSI Chronic Catheter Recalled for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.
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. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).
Plain-English summary
Covidien LLC is voluntarily recalling the Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm (Item Code: 8888128459). The recall is being conducted because the catheters may not meet antimicrobial specifications. The agency has classified this recall as Class II.
The recall covers 72,363 units distributed in the United States and 24,631 units distributed internationally. The affected products are identified by item codes with an expiry date of February 2018 and earlier. Distribution was worldwide, including the US and numerous international markets.
Healthcare providers and consumers should stop using the affected catheters and contact the manufacturer or their supplier for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Catheters
- Hazard
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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