Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall affects 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 is classified as FDA Class II. The hazard involves a risk of harm (loss of sterility) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Cook Inc. is recalling Torcon NB Advantage Catheters due to a potential compromise of sterility. The issue stems from undersealed chevron packaging pouches, which may allow the product to lose its sterile state.
The recalled product is intended for use in the peripheral and coronary vascular system, including the carotid arteries, in angiographic procedures by trained physicians. The recall involves 10 units with Lot Number 9908502 and UDI (01)00827002471856(17)220808(10)9908502.
The products were distributed worldwide, including in the United States and various international countries. Consumers and healthcare providers 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
- 10
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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