The Recall Desk
HighFDA (Devices)·Z-0476-2020·Announced 2019-11-27

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

Cook Inc. is recalling Torcon NB Advantage Catheters because undersealed packaging pouches may compromise sterility. The recall covers units distributed in the US and internationally.

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. While no injuries or illnesses are reported in the source text, the risk of infection from non-sterile medical devices is significant, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

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 NS9712997 and NS9712998, with expiration dates of May 16, 2022, and May 15, 2022, respectively.

The products were distributed worldwide, including in the United States and various international markets. Healthcare providers and facilities should stop using the affected lots 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-NS-JR2 REF (GPN): G10924 Lot Numbers: NS9712997
  • NS9712998 UDIs: (01)00827002109247(17)220516(10)NS9712997
  • (01)00827002109247(17)220515(10)NS9712998

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.

See all →

Same hazard · sterility compromise

See all →