Covidien Recalls Chronic Catheter Kits for Antimicrobial Specification Failure
Covidien LLC is recalling Palindrome Precision 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
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 involves a medical device that may not meet antimicrobial specifications, posing a risk of harm (infection) without reported injuries, which aligns with 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 Precision HSI Chronic Catheter Kit with VenaTrac Stylet (14.5 Fr x 23cm, Item Code: 8888145048CP). The recall is being conducted because the catheters may not meet antimicrobial specifications. The affected products are identified by item codes with 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 agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected catheter kits and contact their supplier or the manufacturer for further instructions. No specific illnesses or injuries are reported in the source text, but the failure to meet antimicrobial specifications presents a potential risk of infection.
The recalled product
- Product
- Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048CP
- 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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