The Recall Desk
HighFDA (Devices)·Z-0481-2020·Announced 2019-11-27

Cook Inc. Recalls Torcon NB Advantage Catheters Due to Packaging Seal Defect

Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers 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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria for potential sterility compromise.

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, in angiographic procedures. The recall includes specific lot numbers 9700773 and 9705822, with reference numbers HNB5.0-38-100-P-4S-NIH and G11749.

The products were distributed worldwide, including nationwide in the United States and in various international countries. Healthcare facilities and consumers should stop using these specific units and contact Cook Inc. for further instructions or replacement.

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): HNB5.0-38-100-P-4S-NIH REF (GPN): G11749 Lot Numbers: 9700773
  • 9705822 UDIs: (01)00827002117495(17)220509(10)9700773
  • (01)00827002117495(17)220513(10)9705822

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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