ConMed Corporation recalls CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190…

Recall date

June 27, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0130-2017

FDA classification

Class II

Brand / firm

ConMed Corporation

Sold / distributed

Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.

Why it was recalled

The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.