POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0537CJDA

Reason: Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.

Code information: UDI-DI: 00821925044555 Lot numbers: CA182543, CA182544, CA182546, CA182548, CA191230

Distribution pattern: Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.