Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure
The FDA is recalling Palindrome SI Chronic Catheter Kits 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
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 (infection) even though specific injuries are not reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Palindrome SI Chronic Catheter Kits with VenaTrac Stylet (14.5 Fr x 28cm, Item Code: 8888145064) manufactured by Covidien LLC. The recall is due to the possibility that the catheters may not meet antimicrobial specifications. The affected units 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. This is classified as an FDA Class II recall.
Consumers and healthcare providers should stop using the affected catheter kits and contact their supplier or the manufacturer for further instructions. The FDA has not reported specific illnesses or injuries associated with this recall in the provided text.
The recalled product
- Product
- Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064
- 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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