Cordis Recalls Sleek OTW PTA Catheters Due to Incorrect Labeling
Cordis Corporation is recalling specific lots of Sleek OTW PTA Dilatation Catheters because they are incorrectly labeled.
What this means for you
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 product is incorrectly labeled without reporting any illnesses or injuries, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Cordis Corporation initiated a recall on January 20, 2011, for its Sleek OTW PTA Dilatation Catheters. The recall covers Model #4261201X (Lot #50027149) and Model #4261501X (Lot #50026688). These medical devices are non-reusable semi-compliant coaxial design catheters with a balloon mounted on the distal tip, used for percutaneous transluminal angioplasty.
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 report any illnesses or injuries associated with the use of these devices.
The affected units were distributed worldwide, specifically in the USA and Germany. Healthcare providers and facilities should check their inventory for these specific model and lot numbers and stop using the affected devices.
The recalled product
- Product
- Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No. 500
- Manufacturer
- Cordis Corporation
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 5
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 #50027149
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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