FDA recall Z-1306-2019

Product

ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 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.

Reason for recall

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

Distribution

Worldwide Distribution: US (Nationwide) and countries of: Austria, Canada, Denmark, Great Britain, Ireland, Japan, Netherlands, OMAN, Poland, QATAR, ROMANIA, SINGAPORE, Spain and Sweden.

Key facts

Status

Terminated

Initiation date

2019-03-21

Report date

2019-05-15

Termination date

2023-01-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Utica, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1306-2019