HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
- Company
- Bovie Medical Corporation
- Recall Initiated
- February 1, 2021
- Recall Number
- Z-1154-2021
- Quantity
- 3862 units
- Firm Location
- Clearwater, FL
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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