HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
This recall is currently active, issued February 1, 2021. It was issued by Bovie Medical Corporation.
- Company
- Bovie Medical Corporation
- Recall Initiated
- February 1, 2021
- Recall Number
- Z-1154-2021
- Quantity
- 3862 units
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of CA and FL.
Lot / Code Info
Catalog Numbers HNM-31-150365 (lots 1017G, 1117B, 1217B, 0418C, 0518D, 0518H, 0618B, 0618D, 0818E, 1018J, 1018M, 1118J, 1218B, 1119B, 0420H, 0820H); HNM-31-150367 (lot 1117D); HNM-31-150368 (lot 1117D).
Root Cause
Device Design
Action Taken
The firm sent "URGENT MEDICAL DEVICE RECALL" (FA-2021-1) and response form to customers on February 1, 2021.
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