Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Defect
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed worldwide.
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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential sterility compromise.
Plain-English summary
Cook Inc. is recalling 20 units of Torcon NB Advantage Catheters due to a potential compromise of sterility. The issue stems from undersealed chevron packaging pouches, which may allow contamination of the medical devices.
The affected catheters are intended for use in the peripheral and coronary vascular system, including the carotid arteries, in angiographic procedures. The specific lot number is 9900974, and the Reference Number (RPN) is HNB5.0-38-65-P-NS-SHK1.0.
These products were distributed worldwide, including nationwide in the United States and in various international countries. Healthcare providers and facilities should stop using the affected catheters and contact Cook Inc. for further instructions.
The recalled product
- Product
- Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheters
- Affected units
- 20
Distribution
Part of a larger recall action
This product is one of 71 recalled by Cook Inc. 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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