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Recall Observatory FDA recall evidence

Device product

HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.

Z-1154-2021

February 01, 2021

Class II

Product summary

Firm
Bovie Medical Corporation
Event
Event 87274
Status
Ongoing
Classification
Class II
Quantity
3862 units
Official record key
device-enforcement:Z-1154-2021

Official wording

Reason: 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.

Code information: 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).

Distribution pattern: US Nationwide distribution in the states of CA and FL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.