The Recall Desk

FDA (Devices) recall action 74774

ConMed Corporation recalled 7 products on 2016-10-26

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2016-10-26
Critical
0
Units
—

Why these products were recalled

The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

The agency’s own wording, quoted from the enforcement report.

1–7 of 7

  • ModerateFDA (Devices)··2016-10-26

    ConMed CORE Suction Irrigation Handpiece Recalled for Packaging Seal Crease

    ConMed is recalling CORE Suction Irrigation Handpieces because a crease in the packaging seal may create an open channel that compromises the product's sterility.

    Product
    CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-10-26

    ConMed CORE Suction Irrigation Handpiece Recalled for Packaging Seal Defect

    ConMed is recalling CORE Suction Irrigation Handpieces because a crease in the packaging seal may compromise the product's sterility.

    Product
    CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-10-26

    ConMed CORE Trumpet Handpiece Recalled for Packaging Seal Crease

    ConMed is recalling CORE Trumpet Handpieces because a crease in the packaging seal may create an open channel that compromises the product's sterility.

    Product
    CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-10-26

    ConMed CORE Trumpet Handpiece Recalled for Potential Sterility Compromise

    ConMed is recalling CORE Trumpet Handpieces because packaging creases may create open channels that compromise sterility.

    Product
    CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-10-26

    ConMed Recalls CORE Suction Irrigation Handpieces Due to Packaging Seal Defects

    ConMed Corporation is recalling CORE Suction Irrigation Handpieces because packaging seal creases may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-10-26

    ConMed Recalls CORE Suction Irrigation Handpieces Due to Packaging Seal Creases

    ConMed is recalling CORE Suction Irrigation Handpieces because creases in the packaging seal may create open channels that compromise the product's sterility.

    Product
    CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2016-10-26

    ConMed Recalls CORE Suction Irrigation Handpiece Y-Tubing Sets

    ConMed is recalling CORE Suction Irrigation Handpiece Y-Tubing sets because a crease in the packaging seal may compromise sterility.

    Product
    CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The CORE Suction/Irrigation Y Tubing Set with Trumpet Valves (CD8200) is indicated for use in gynecological and abdominal surgery for
    Category
    Distribution
    0 states