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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Cook Inc.
- 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
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