Cook Torcon NB Advantage Catheters Recalled for Packaging Seal Defect
Cook Inc. is recalling 35 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are used in angiographic procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 potential sterility compromise in a medical device used in vascular procedures, which poses 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 35 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.
These catheters are intended for use in the peripheral and coronary vascular system, including the carotid arteries, during angiographic procedures by trained physicians. The recall covers units distributed nationwide in the United States and in various countries worldwide.
Healthcare facilities and consumers should stop using the affected products immediately. The specific lot numbers involved are NS9708134, NS9708135, and NS9713695. Users should contact Cook Inc. for further instructions on returning or disposing of the recalled items.
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
- 35
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- REF (RPN): HNB5.0-38-100-P-NS-HN4 REF (GPN): G07940 Lot Numbers: NS9708134
- NS9708135
- NS9713695 UDIs: (01)00827002079403(17)220517(10)NS9708134
- (01)00827002079403(17)220516(10)NS9708135
- (01)00827002079403(17)220516(10)NS9713695
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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