BPB medica CEMIX Cement Mixing System Recalled for Sterility Concerns
Biopsybell S.R.L. is recalling 5 units of the BPB medica CEMIX cement mixing system because products labeled as sterile 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the failure of a sterile medical device to be sterilized poses a significant risk of infection, aligning with the Severe classification for Class II recalls with potential for serious harm.
Plain-English summary
Biopsybell S.R.L. is recalling 5 units of the BPB medica CEMIX, product number KVTMIXN, a vertebroplasty-kyphoplasty cement mixing system. The recall was initiated because the products were labeled as sterile but may not have been sterilized.
The affected units are identified by batch number 19123253. These products were distributed nationwide in the United States, specifically in the states of Mississippi and Kentucky.
Healthcare providers and facilities that have received these units should stop using them immediately and contact the recalling firm for instructions on return or disposal. Patients who have already received treatment with these devices should contact their healthcare provider for further guidance.
The recalled product
- Product
- BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
- Manufacturer
- BIOPSYBELL S.R.L.
- Affected units
- 5
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: 19123253
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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