The Recall Desk
HighFDA (Devices)·Z-0425-2020·Announced 2019-11-27

Cook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns

Cook Inc. is recalling 165 Torcon NB Advantage Catheters because undersealed packaging pouches may have compromised 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 (sterile medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Cook Inc. is recalling 165 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.

These 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 affected units were distributed worldwide and nationwide in the United States, including specific states and territories, as well as in numerous international countries.

The source text does not specify instructions for consumers or healthcare providers regarding the disposition of the recalled units. No illnesses or injuries are reported in the source text.

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
165

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-SIM1 REF (GPN): G04922 Lot Numbers: 9700385
  • 9713001
  • 9726999 UDIs: (01)00827002049222(17)220509(10)9700385
  • (01)00827002049222(17)220516(10)9713001
  • (01)00827002049222(17)220515(10)9726999

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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