The Recall Desk
HighFDA (Devices)·Z-0451-2020·Announced 2019-11-27

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

Cook Inc. is recalling 470 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 potential sterility compromise in a medical device used in vascular procedures, which poses 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 470 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.

Healthcare facilities and distributors should stop using the affected catheters and contact Cook Inc. for instructions on how to return the products. 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
470

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): HNB5.0-38-100-P-NS-MPA REF (GPN): G08153 Lot Numbers: 9696901
  • 9700384
  • 9701377
  • 9708543
  • 9709229 UDIs: (01)00827002081536(17)220508(10)9696901
  • (01)00827002081536(17)220513(10)9700384
  • (01)00827002081536(17)220509(10)9701377
  • (01)00827002081536(17)220514(10)9708543
  • (01)00827002081536(17)220509(10)9709229

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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