Cordis Recalls Sleek OTW PTA Catheters Due to Incorrect Labeling
Cordis Corporation is recalling specific lots of Sleek OTW PTA Dilatation Catheters because the products are incorrectly labeled.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source explicitly states the issue is incorrect labeling without reporting any illnesses or injuries, fitting the criteria for minor labeling errors.
Plain-English summary
Cordis Corporation initiated a recall of its Sleek OTW PTA Dilatation Catheters on January 20, 2011. The recall covers Model #4261201X (Lot #50027149) and Model #4261501X (Lot #50026688). The FDA classified this as a Class II recall.
The reason for the recall is that the product is incorrectly labeled. The source text does not specify the nature of the labeling error or any associated health risks.
The affected products were distributed worldwide, specifically in the USA and Germany. No illnesses or injuries have been reported in the source text. Healthcare providers should stop using the affected lots and contact Cordis Corporation for further instructions.
The recalled product
- Product
- Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization…
- Manufacturer
- Cordis Corporation
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 1
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)
- Lot #50026688.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Cordis Corporation 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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