Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 405 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are 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 used in invasive procedures. While no specific injuries are reported in the text, the risk of infection from non-sterile devices in vascular systems represents a significant health hazard, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cook Inc. is recalling 405 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 due to a potential compromise of the sterility of the products. The issue stems from undersealed chevron in the packaging pouches, which may allow contamination.
The affected units were distributed worldwide, including in the United States and various international countries. Specific lot numbers and UDI codes are listed in the recall documentation. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.
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
- 405
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 (9)
- REF (RPN): HNB5.0-38-100-P-NS-SIM2 REF (GPN): G05976 Lot Numbers: 9700386
- 9701378
- 9707469
- 9710399
- 9713002 UDIs: (01)00827002059764(17)220511(10)9700386
- (01)00827002059764(17)220510(10)9701378
- (01)00827002059764(17)220514(10)9707469
- (01)00827002059764(17)220510(10)9710399
- (01)00827002059764(17)220516(10)9713002
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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