Biopsybell 10 Gauge Drill Recalled for Potential Sterility Failure
Biopsybell S.R.L. is recalling 75 units of 10 Gauge Drills labeled as sterile that may not have been sterilized.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class II, and the hazard involves a medical device that may not be sterile, posing a significant risk of infection or serious injury.
Plain-English summary
Biopsybell S.R.L. is recalling 75 units of 10 Gauge Drills, code INTVM-DRL, lot 20102486. The recall is due to the possibility that the products were distributed labeled as sterile but may not have been sterilized.
The affected products were distributed nationwide in the United States, specifically in the states of Mississippi and Kentucky. No specific dates of distribution or additional distribution details are provided in the source text.
Consumers and healthcare facilities should stop using the affected 10 Gauge Drills immediately. Users should contact Biopsybell S.R.L. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- 10 GAUGE DRILL, CODE INTVM-DRL
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 75
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: 20102486
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.
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