Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Failure
Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications.
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 recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric, as it involves a product that could cause temporary or medically reversible health consequences.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm (Item Code: 8888145064CP). The recall is being conducted by the manufacturer, Covidien LLC, 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. A total of 72,363 units were distributed in the United States and 24,631 units were distributed internationally. The products were distributed nationwide in the U.S. and to numerous countries worldwide, including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, and others.
Healthcare providers and facilities should stop using the affected catheters and contact the manufacturer for instructions on how to return the products. Consumers who have purchased these devices should consult their healthcare provider for guidance.
The recalled product
- Product
- Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP
- 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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