Biopsybell 10G Coaxial Cannula Recalled for Potential Sterility Failure
Biopsybell is recalling 40 units of 10G coaxial cannulas labeled as sterile but potentially not sterilized. The units were distributed in Mississippi and Kentucky.
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 labeled as sterile that may not be, creating a risk of infection. This fits the rubric for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no illnesses or injuries are explicitly stated in the source.
Plain-English summary
Biopsybell S.R.L. is recalling 40 units of 10G coaxial cannulas with Tuohy connection (Code INTVM-CC, Lot 20102495). The recall was initiated because the products were labeled as sterile but may not have been sterilized.
The affected units were distributed nationwide in the United States, specifically within the states of Mississippi and Kentucky. No specific dates of distribution or number of affected patients are provided in the source text.
Consumers and healthcare facilities should stop using the affected cannulas and contact Biopsybell S.R.L. for further instructions or a return.
The recalled product
- Product
- 10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 40
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)
- LOT: 20102495
Distribution
Part of a larger recall action
This product is one of 19 recalled by BIOPSYBELL S.R.L. 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 19 products in this recall →Related recalls
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