BPB medica Osteobell Explant Needle Recalled for Sterility Concerns
BPB medica is recalling Osteobell Explant Needles 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 infection or harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
BPB medica is recalling 50 units of the OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111. The recall is being conducted because the products were labeled as sterile but may not have been sterilized.
The affected units are identified by Batch Number 20061439. The products were distributed in the United States, specifically in the states of Mississippi and Kentucky.
Consumers and healthcare providers should stop using the affected needles and contact the recalling firm, BIOPSYBELL S.R.L., for further instructions.
The recalled product
- Product
- BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 50
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)
- BATCH Numbers: 20061439
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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