—#171675

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.

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K172940
Affected lot / code info: 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: Excluded Lot Codes for Cat. Number TRS190SB2 201807114, 201807275, 201807175 201807304

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

Root cause (FDA determination)

Process control

Action the firm took

The firm, CONMED Corporation, issued an "URGENT: MEDICAL DEVICE RECALL" notification dated March 21, 2019 via USPS First Class on March 21, 2019 to its customers. The notification describes the product, problem and actions to be taken. The customers were instructed to review inventory, contact all of those departments within your facility and any other facilities that may have received affected products, complete the business reply form by fax to: 315-624-3225, Attn: Field Action Support Team, or email to: TRS2019@conmed.com, even if you do not have any affected devices to return; and return business reply form with the devices to: CONMED Corporation 525 French Road, Utica, NY 13502 USA, Return via: UPS Account # W5Y243 (no charge to your facility) Please do not return open or used devices. Questions or requests, contact the Field Action Support Team at +1-800-448-6506 (8:00am to 7:00pm EST Monday through Friday), fax to +1 315-624-3225, or email TRS2019@conmed.com.

Recalling firm

Firm: Conmed Corporation
Address: 310 Broad St, Utica, New York 13501-1203

Distribution

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.

Timeline

Recall initiated: 2019-03-21
Terminated: 2023-01-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171675. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.