Medical device recalls Moderate risk

Conmed Corporation recalls ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval Syste…

Recall date
March 21, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1304-2019
FDA classification
Class II
Brand / firm
Conmed Corporation
Sold / distributed
Worldwide Distribution: US (Nationwide) and countries of: Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, OMAN, Poland, QATAR, ROMANIA, SINGAPORE, Spain and Sweden.

Why it was recalled

Voids in the seal or a partial seal results in an open channel and may compromise the 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

ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System" by CONMED is a sterile disposable pouch used with a dedicated introducer for the encapture and removal of an organ or tissue from the body cavity during laparoscopic surgery.

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