Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 93 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised the sterility of the devices.
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 compromise of sterility for an invasive medical device, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Cook Inc. is recalling 93 units of Torcon NB Advantage Catheters. The recall was initiated because the packaging pouches for these devices may have undersealed chevron seals, which poses a potential risk of compromising the sterility of the catheters.
These 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 affected units were distributed worldwide, including nationwide in the United States and in various international countries.
Healthcare providers and facilities should check their inventory for the specific lot number 9715474 and reference numbers HNB6.0-38-100-P-NS-JR4 and G04788. If these devices are found, they should be removed from use and returned to Cook Inc. or the distributor in accordance with the recall 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
- 93
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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