Bard MAX-CORE Biopsy Instruments Recalled for Self-Activation Risk
Bard Peripheral Vascular Inc is recalling 7,995 Bard MAX-CORE Disposable Core Biopsy Instruments due to a risk of self-activation-related issues.
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 medical device with a risk of self-activation, which poses a potential risk of harm to patients. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Bard Peripheral Vascular Inc is recalling 7,995 units of the Bard MAX-CORE Disposable Core Biopsy Instrument, specifically the 18g x 20cm size (Product Code MC1820). The affected units are identified by Lot Numbers REYA2017 and REYC2853. This single-patient-use device is used for core biopsies.
The recall was initiated due to the risk of self-activation-related issues. The source text does not specify the exact nature of the self-activation or report any associated injuries or illnesses.
The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries such as France, Mexico, the United Kingdom, Germany, and Japan. Consumers and healthcare providers should stop using these specific instruments and contact the recalling firm for further instructions.
The recalled product
- Product
- BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are…
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 7,995
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 (2)
- Product Code: MC1820 Gauge x Lengh: 18g x 20cm Lot Numbers: REYA2017
- REYC2853
Distribution
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