The Recall Desk
HighFDA (Devices)·Z-0452-2020·Announced 2019-11-27

Cook Torcon NB Advantage Catheters Recalled for Potential Sterility Compromise

Cook Inc. is recalling Torcon NB Advantage Catheters due to potential sterility compromise caused by undersealed packaging pouches.

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.

Plain-English summary

Cook Inc. is recalling 145 units of Torcon NB Advantage Catheters. The recall is due to a potential compromise of the sterility of the products, which may result from 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 9700004, 9703928, and NS9703929.

The products were distributed worldwide and nationwide in the United States, including in Puerto Rico. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected devices if found.

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
145

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): HNB5.0-35-100-P-10S-PIG REF (GPN): G08201 Lot Numbers: 9700004
  • 9703928
  • NS9703929 UDIs: (01)00827002082014(17)220511(10)9700004
  • (01)00827002082014(17)220510(10)9703928
  • (01)00827002082014(17)220508(10)NS9703929

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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