The Recall Desk
HighFDA (Devices)·Z-0450-2020·Announced 2019-11-27

Cook Torcon NB Advantage Catheters Recalled for Packaging Seal Defect

Cook Inc. is recalling 35 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are used in angiographic procedures.

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. The hazard 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 35 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.

These catheters are intended for use in the peripheral and coronary vascular system, including the carotid arteries, during angiographic procedures by trained physicians. The recall covers units distributed nationwide in the United States and in various countries worldwide.

Healthcare facilities and consumers should stop using the affected products immediately. The specific lot numbers involved are NS9708134, NS9708135, and NS9713695. Users should contact Cook Inc. for further instructions on returning or disposing of the recalled items.

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
35

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): HNB5.0-38-100-P-NS-HN4 REF (GPN): G07940 Lot Numbers: NS9708134
  • NS9708135
  • NS9713695 UDIs: (01)00827002079403(17)220517(10)NS9708134
  • (01)00827002079403(17)220516(10)NS9708135
  • (01)00827002079403(17)220516(10)NS9713695

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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