The Recall Desk
HighFDA (Devices)·Z-0457-2020·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 the sterility of the devices.

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 risk-of-harm product (medical device) where the hazard is a potential sterility compromise, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Cook Inc. is recalling 20 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.

The affected 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 specific lot numbers involved are 9926069 and NS9926068.

The products were distributed worldwide and nationwide in the United States, including in Puerto Rico. Consumers and healthcare providers should stop using the affected products 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
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 (3)

  • REF (RPN): HNB5.0-38-80-P-NS-C3 REF (GPN): G09521 Lot Numbers: 9926069
  • NS9926068 UDIs: (01)00827002095212(17)220822(10)9926069
  • (01)00827002095212(17)220809(10)NS9926068

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.

See all →

Same hazard · sterility compromise

See all →