Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 951 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are used in angiographic procedures.
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 is classified as FDA Class II and involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Cook Inc. is recalling 951 units of Torcon NB Advantage Catheters. The recall is due to a potential compromise of the sterility of the products caused by undersealed chevron in the packaging pouches.
These catheters 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 affected units were distributed worldwide, including in the United States and various international countries.
Consumers and healthcare providers should stop using the affected catheters and contact Cook Inc. for further instructions or a replacement. The recall is classified as Class II by the FDA.
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
- 951
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 (20)
- REF (RPN): HNB5.0-38-100-P-NS-H1 REF (GPN): G06005 Lot Numbers: 9698823
- 9702704
- 9702705
- 9702778
- 9702809
- 9703680
- 9707588
- 9714540
- 9715463
- 9716515
- 9716516
- 9716517
- 9719485 UDIs: (01)00827002060050(17)220508(10)9698823
- (01)00827002060050(17)220510(10)9702704
- (01)00827002060050(17)220510(10)9702705
- (01)00827002060050(17)220513(10)9702778
- (01)00827002060050(17)220509(10)9702809
- (01)00827002060050(17)220510(10)9703680
- (01)00827002060050(17)220509(10)9707588
- (01)00827002060050(17)220509(10)9714540
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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