The Recall Desk
HighFDA (Devices)·Z-0444-2020·Announced 2019-11-27

Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise product sterility. The recall affects units 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 is classified as FDA Class II, and the hazard involves a risk of harm (sterility compromise) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Cook Inc. is recalling 20 units of Torcon NB Advantage Catheters due to a potential compromise of sterility. The issue stems from undersealed chevron components in the packaging pouches, which may allow contamination of the medical devices.

These catheters are intended for use in the peripheral and coronary vascular system, including the carotid arteries, during angiographic procedures. The affected products were distributed nationwide in the United States and in various countries worldwide, including Australia, Belgium, Canada, China, and the United Kingdom.

Healthcare providers and facilities should stop using the affected lot numbers (NS9904021, NS9913224, NS9945395) and contact Cook Inc. for further instructions on returning or disposing of the products.

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
Hazard
Affected units
20

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 (5)

  • REF (RPN): HNB5.0-38-65-P-NS-H1 REF (GPN): G06607 Lot Numbers: NS9904021
  • NS9913224
  • NS9945395 UDIs: (01)00827002066076(17)220801(10)NS9904021
  • (01)00827002066076(17)220802(10)NS9913224
  • (01)00827002066076(17)220823(10)NS9945395

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

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.

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Same hazard · sterility compromise

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