Reported Mar 10, 2021 · Ongoing
ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of…
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?
- ConMed Disposable
- Bipolar Ablators - Product Usageintended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 Catalog Numbers C3390A (lots 0317F, 0417B, 0517B, 0517D, 0517J, 0617D, 0617F, 0617H, 0617K, 0717A, 0717G, 0817B, 0917G, 0917J, 1017C, 1017E, 1017J, 1117B, 0418C) 2 C3350A (lots 0317F, 0417B, 0517B, 0517G, 0717C, 0817D, 0917C, 0917E) 3 C3350NA (lots 0317F, 0517G, 0817F) 4 C2455NA (lots 0317F, 0517B, 0717E, 1017C, 1017E) 5 C1860NA (lots 0317F, 0517B, 0717E, 0817F, 1017G, 0418E) 6 C3390NA (lots 0317F, 0517G, 0817H, 1017J, 0418E, 0518F, 1218C). - Amount recalled
- 5270 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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