The Recall Desk
HighFDA (Devices)·Z-1028-2016·Announced 2016-03-09

Cook Inc. Recalls Kopans Breast Lesion Localization Needles

Cook Inc. is recalling 134 Kopans Breast Lesion Localization Needles because they may have been exposed to body fluids during processing, posing a potential risk of blood-borne pathogen transmission.

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 high-risk pathogen (blood-borne pathogens) and a medical device, but the source explicitly states the risk is minimal to non-existent due to sterilization, fitting the 'High' criteria for risk-of-harm products where injury has not been reported.

Plain-English summary

Cook Inc. is voluntarily recalling 134 units of the Kopans Breast Lesion Localization Needle, catalog number DKBL-20-7.0-A, lot number 6215428, manufactured on September 17, 2015. The recall was initiated because the devices were potentially exposed to body fluids during the processing stage.

The potential adverse event associated with this exposure is the transmission of blood-borne pathogens. However, the source text notes that the risk of transmission is considered minimal to non-existent because the devices were sterilized after the potential exposure occurred.

The affected products were distributed nationwide, including in Arizona, California, Georgia, Illinois, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New York, Ohio, Oklahoma, and Pennsylvania. Consumers and healthcare providers should stop using these specific needles and contact Cook Inc. for instructions on return or replacement.

The recalled product

Product
Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip during
Manufacturer
Cook Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
134

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 (1)

  • Catalog # DKBL-20-7.0-A Lot # 6215428 date of manufacture 09/17/2015

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Related recalls

Same manufacturer · Cook Inc.

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