Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 45 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 sterility compromise in a medical device used in vascular procedures. This represents a risk of harm (infection) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Cook Inc. is recalling 45 units of Torcon NB Advantage Catheters. The recall was initiated because the packaging pouches for these devices may have undersealed chevron seals, which could potentially compromise the sterility of the catheters.
The affected products 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 recall covers units distributed worldwide, including nationwide distribution in the United States and in various international countries.
Healthcare facilities and distributors should stop using the affected catheters and contact Cook Inc. for instructions on how to return the products. The specific lot numbers and Unique Device Identifiers (UDIs) for the affected units are listed in the official recall documentation.
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
- 45
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 (15)
- REF (RPN): HNB5.0-38-80-P-NS-HS2 REF (GPN): G10598 Lot Numbers: NS9904742
- NS9906243
- NS9906244
- NS9914968
- NS9914970
- NS9928941
- NS9943480
- NS9943481 UDIs: (01)00827002105980(17)220731(10)NS9904742
- (01)00827002105980(17)220731(10)NS9906243
- (01)00827002105980(17)220801(10)NS9906244
- (01)00827002105980(17)220805(10)NS9914968
- (01)00827002105980(17)220805(10)NS9914970
- (01)00827002105980(17)220809(10)NS9928941
- (01)00827002105980(17)220826(10)NS9943480
- (01)00827002105980(17)220822(10)NS9943481
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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