Reported May 27, 2020 · Terminated
Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS,…
Bovie Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bovie Medical Corporation · 5115 Ulmerton Rd · Clearwater, FL · 33760-4004
Is this the product you have?
- Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP
- and APYX-150-BPS - Product Usagefor electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures
- Lot codes and dates
- The following Catalog numbers which were distributed
- from 06/01/2016 through present
BVX-044-BPSBVX-044-BPPBVX-150-BPPBVX-150-BPSAPYX-044-BPSAPYX-150-BPPAPYX-150-BPS
- Amount recalled
- 13,948
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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