Biopsybell 8G Direct Working Cannula Bevel Tip Recall for Sterility Concerns
Biopsybell is recalling 8G Direct Working Cannula Bevel Tips labeled as sterile that may not have been sterilized. The recall affects 30 units distributed in Mississippi and Kentucky.
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 recall is classified as FDA Class II and involves a medical device that may not be sterile, posing a significant risk of infection or serious injury to patients.
Plain-English summary
Biopsybell S.R.L. is recalling 30 units of 8G Direct Working Cannula Bevel Tip, Code INTVM-DWCB, Lot 20061432. The recall was initiated because the products were 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. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and consumers should stop using the affected cannula tips immediately. Users should contact Biopsybell S.R.L. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 30
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: 20061432
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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