Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
Cook Inc. is recalling 25 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The products were 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, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cook Inc. is recalling 25 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 lot number is 9903997, with Reference Number HNB5.0-38-80-P-NS-MIK and GPN G06108.
The products were distributed worldwide, including nationwide in the United States and in various countries such as Australia, Belgium, Canada, China, and the United Kingdom. Healthcare providers and facilities should check their inventory for this specific lot 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
- 25
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
Same manufacturer · Cook Inc.
See all →- HighSkinny Needle with Chiba Tip recalled for debris contamination
FDA (Devices) · 2021-12-29
- HighCook Flexor Check-Flo Introducer recalled for size mislabeling
FDA (Devices) · 2021-12-22
- ModerateFlexor Check-Flo Introducer Recalled for Mislabeled Caliber Size
FDA (Devices) · 2021-12-22
- HighTransseptal Needles Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
- HighTransseptal Needle with Catheter Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12