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Recall Observatory FDA recall evidence

Device product

ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2 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.

Z-1305-2019

March 21, 2019

Class II

Product summary

Firm
Conmed Corporation
Event
Event 82478
Status
Terminated
Classification
Class II
Quantity
11835
Official record key
device-enforcement:Z-1305-2019

Official wording

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

Code information: Lot codes for product manufactured to and including the dates listed below, with the exclusions noted below for each catalog number: Beginning Manufacture Date: April 26, 2018 Beginning Lot Code: 20180426X Ending Manufacture Date: February 15, 2019 Ending Lot Code: 20190215X Excluded Anchor Tissue Retrieval System" Lot Codes - 1. All alpha/numeric lot codes (e.g. lots 68A8T or 19A8T) 2. All numeric lot codes ending with the number 9 (e.g. Lot code 201902159) 3. All excluded numeric lot codes listed in the tables below for each specific catalog number: Excluded Lot Codes for Cat. Number TRS175SB2: 201808025 201809215 201901164 201901184 201901224 201809205 201901154 201901174 201901214

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

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