Cook Torcon NB Advantage Catheters Recalled for Sterility Compromise
Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise from undersealed packaging pouches.
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, which poses a risk of harm (infection) to patients, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cook Inc. is recalling 35 units of Torcon NB Advantage Catheters. These medical devices are intended for use in the peripheral and coronary vascular system, including the carotid arteries, in angiographic procedures by trained physicians.
The recall is being conducted because of a potential compromise of the sterility of the products. This issue is attributed to an undersealed chevron in the packaging pouches. The affected units were distributed worldwide, including nationwide in the United States and in various international countries.
Consumers and healthcare providers should stop using the affected catheters immediately. They should contact Cook Inc. for further instructions on how to return or dispose of the products.
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 (11)
- REF (RPN): HNB5.0-38-80-P-NS-HS1 REF (GPN): G10599 Lot Numbers: NS9903072
- NS9904741
- NS9914967
- NS9928940
- NS9933626
- NS9942737 UDIs: (01)00827002105997(17)220731(10)NS9903072
- (01)00827002105997(17)220801(10)NS9904741
- (01)00827002105997(17)220805(10)NS9914967
- (01)00827002105997(17)220809(10)NS9928940
- (01)00827002105997(17)220816(10)NS9933626
- (01)00827002105997(17)220826(10)NS9942737
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.
See all 71 products in this recall →Related recalls
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