Reported Mar 10, 2021 · Ongoing
HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft…
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?
- HNM Disposable
- Bipolar Ablators - Product Usageintended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures
- Lot codes and dates
Catalog Numbers HNM-31-150365 (lots 1017G1117B1217B0418C0518D0518H0618B0618D0818E1018J1018M1118J1218B1119B0420H0820H)HNM-31-150367 (lot 1117D)HNM-31-150368 (lot 1117D)
- Amount recalled
- 3862 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
This product could cause temporary or reversible health problems — stop using it.
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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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