Biopsybell 10G Direct Single Access Devices Recalled for Sterility Concerns
Biopsybell S.R.L. is recalling 330 units of 10G Direct Single Access devices because they were labeled as sterile but may not have been sterilized.
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 medical device that may not be sterile, posing a risk of harm (infection) without reported illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biopsybell S.R.L. is recalling 330 units of 10G Direct Single - Access devices, identified by the code INTVM-DSBAK. The recall affects specific lots: 2001201, 2003859, 20051288, and 20061419.
The reason for the recall is that the products were labeled as sterile but may not have been sterilized. This potential lack of sterilization poses a risk of infection if the devices are used as intended.
The devices were distributed nationwide in the United States, specifically in the states of Mississippi (MS) and Kentucky (KY). Healthcare facilities and consumers who have these specific lots should stop using the devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 330
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 (4)
- LOT: 2001201
- 2003859
- 20051288
- 20061419
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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