Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 45 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were 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 potential sterility compromise in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cook Inc. is recalling 45 units of Torcon NB Advantage Catheters. The recall was initiated due to a potential compromise of the sterility of the products. This issue is attributed to undersealed chevron in the packaging pouches.
The affected catheters are intended for use in the peripheral and coronary vascular system, including the carotid arteries, in angiographic procedures by physicians trained and experienced in angiographic techniques. The specific lot number is 9930261, and the Reference Product Number (RPN) is HNB5.0-NT-80-P-NS-MPA.
The devices were distributed worldwide, including nationwide distribution in the United States and in numerous international countries. Healthcare providers and facilities should check their inventory for this specific lot number and stop using the affected devices if found.
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
- 45
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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