The Recall Desk
HighFDA (Devices)·Z-0467-2020·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.

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, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Cook Inc. is recalling 10 units of Torcon NB Advantage Catheters. These medical devices are intended for use in the peripheral and coronary vascular system, including the carotid arteries, during angiographic procedures by trained physicians.

The recall is due to a potential compromise of the sterility of the products. This issue is caused by undersealed chevron in the packaging pouches. The affected lot numbers are NS9906320 and NS9906321.

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. Users should stop using the affected catheters and contact Cook Inc. for further instructions.

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): HNB5.0-38-80-P-NS-JR2 REF (GPN): G10733 Lot Numbers: NS9906320
  • NS9906321 UDIs: (01)00827002107335(17)220731(10)NS9906320
  • (01)00827002107335(17)220801(10)NS9906321

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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