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Recall Observatory FDA recall evidence

Device product

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

Z-1153-2021

February 01, 2021

Class II

Product summary

Firm
Bovie Medical Corporation
Event
Event 87274
Status
Ongoing
Classification
Class II
Quantity
5894 units
Official record key
device-enforcement:Z-1153-2021

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 7201 (lots 0217H, 0317J, 0417B, 0417F, 0417H, 0618K, 0718B, 0718D, 0718F, 0419J, 0519J, 0120F, 0420B, 0720K, 0720M, 0820L, 0117D, 0117F, 1020L); 7205 (lots 0217B, 0317L); 7206 (lots 0217B, 0317L); 7201-01 (lots 0920B, 0920D, 0920H); 7203 (0217F, 0317B, 0317L, 0417H).

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.