Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise
Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise caused by undersealed packaging pouches.
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.
Plain-English summary
Cook Inc. is recalling 90 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 was initiated because of a potential compromise of the sterility of the products. This issue is attributed to undersealed chevron in the packaging pouches.
The affected products were distributed worldwide and nationwide in the United States. The specific lot numbers involved are 9700383 and NS9701376. Users should stop using these devices and contact the manufacturer for further 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
- 90
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 (3)
- REF (RPN): HNB5.0-38-100-P-NS-JL4 REF (GPN): G05923 Lot Numbers: 9700383
- NS9701376 UDIs: (01)00827002059238(17)220510(10)9700383
- (01)00827002059238(17)220508(10)NS9701376
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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