The Recall Desk
HighFDA (Devices)·Z-0468-2020·Announced 2019-11-27

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

Cook Inc. is recalling 232 Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The devices are 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 used in vascular procedures, which presents 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 232 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 is due to the potential compromise of the sterility of the products. This issue arises from an undersealed chevron in the packaging pouches. The affected units are identified by specific Reference (RPN) HNB5.0-38-110-P-12S-PIG, Reference (GPN) G10741, and Lot Numbers 9706696, 9707671, 9709328, 9711384, and 9718538.

The affected products were distributed worldwide, including nationwide in the United States and in various international countries. Healthcare providers and facilities should check their inventory for these specific lot numbers and discontinue use of the affected catheters.

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
232

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 (9)

  • REF (RPN): HNB5.0-38-110-P-12S-PIG REF (GPN): G10741 Lot Numbers: 9706696
  • 9707671
  • 9709328
  • 9711384
  • 9718538 UDIs: (01)00827002107410(17)220513(10)9706696
  • (01)00827002107410(17)220514(10)9707671
  • (01)00827002107410(17)220515(10)9709328
  • (01)00827002107410(17)220515(10)9711384
  • (01)00827002107410(17)220516(10)9718538

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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