The Recall Desk
HighFDA (Devices)·Z-0427-2020·Announced 2019-11-27

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

Cook Inc. is recalling 791 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices were 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 potential sterility compromise in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cook Inc. is recalling 791 units of Torcon NB Advantage Catheters. These medical devices 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 recall was initiated due to a potential compromise of the sterility of the products. The source text identifies the cause as an undersealed chevron in the packaging pouches. The affected units were distributed worldwide, including in the United States and various international countries.

Physicians and healthcare facilities should stop using the affected catheters and contact Cook Inc. for further instructions. The specific lot numbers and UDI codes for the recalled units are listed in the official recall documentation.

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
791

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 (17)

  • REF (RPN): HNB5.0-38-100-P-NS-JR4 REF (GPN): G05922 Lot Numbers: 9700390
  • 9705827
  • 9709327
  • 9710351
  • 9715466
  • 9715476
  • 9716493
  • 9716792
  • 9719152 UDIs: (01)00827002059221(17)220508(10)9700390
  • (01)00827002059221(17)220513(10)9705827
  • (01)00827002059221(17)220513(10)9709327
  • (01)00827002059221(17)220514(10)9710351
  • (01)00827002059221(17)220516(10)9715466
  • (01)00827002059221(17)220516(10)9715476
  • (01)00827002059221(17)220517(10)9716493
  • (01)00827002059221(17)220509(10)9716792
  • (01)00827002059221(17)220511(10)9719152

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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