The Recall Desk
HighFDA (Devices)·Z-0445-2020·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 sterility. The recall affects units distributed in the US and internationally.

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. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it does not meet the criteria for Severe (4) as there are no reports of hospitalization or significant injury.

Plain-English summary

Cook Inc. is recalling 10 units of Torcon NB Advantage Catheters due to a potential compromise of sterility. The issue stems from undersealed chevron packaging pouches, which may allow contamination of the medical devices.

The affected catheters are intended for use in the peripheral and coronary vascular system, including the carotid arteries, during angiographic procedures. The recall covers specific lot numbers NS9913495 and NS9930288, with reference numbers HNB5.0-35-80-P-2S-C2 and G06622.

The products were distributed worldwide, including nationwide in the United States and in numerous international countries. Healthcare providers and facilities should stop using the affected lots and contact Cook Inc. for further instructions on return or disposal.

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
10

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): HNB5.0-35-80-P-2S-C2 REF (GPN): G06622 Lot Numbers: NS9913495
  • NS9930288 UDIs: (01)00827002066229(17)220805(10)NS9913495
  • (01)00827002066229(17)220812(10)NS9930288

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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