medical Class II Updated 2019-05-15

Conmed Corporation recalls ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX)

Recalled Product

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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
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 TRS100SB2: 201805095 201806055 201809265 201810314 201811224 201812114 201805144 201806115 201809285 201811054 201811234 201812124 201805145 201807134 201810014 201811064 201811264 201812144 201805194 201807245 201810094 201811074 201811274 201812174 201805214 201808155 201810154 201811084 201811284 201812184 201805255 201808164 201810164 201811124 201811304 201812204 201805284 201808165 201810184 201811134 201812034 201812214 201805295 201808205 201810194 201811144 201812044 201901024 201805315 201808214 201810224 201811154 201812054 201901034 201806015 201808225 201810234 201811164 201812064 201901044 201806045 201808234 201810244 201811204 201812074 201901074 201806054 201809255 201810254 201811214 201812104 -----
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