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 covers units distributed in the US and internationally.
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 potential sterility compromise in a medical device used in invasive procedures. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cook Inc. is recalling Torcon NB Advantage Catheters due to a potential compromise of sterility. The issue stems from undersealed chevron seals in the packaging pouches, which may allow contamination of the medical devices.
The recalled products are intended for use in the peripheral and coronary vascular system, including the carotid arteries, in angiographic procedures. The recall affects five units with the specific reference number HNB5.0-38-70-P-NS-SHK1.0, GPN G27689, and Lot Number NS9904739.
Distribution was worldwide, including nationwide distribution in the United States and in numerous international countries. Healthcare providers and facilities should stop using these specific units 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
- 5
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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