The Recall Desk

FDA (Devices) recall action 76482

ConMed Corporation recalled 5 products on 2017-04-19

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2017-04-19
Critical
0
Units
—

Why these products were recalled

For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.

For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were Sterile.

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

1–5 of 5

  • HighFDA (Devices)··2017-04-19

    ConMed Recalls Hyfrecator 2000 ESU Cartons with Non-Sterile Handpiece Sheaths

    ConMed is recalling Hyfrecator 2000 ESU cartons because they were packaged with non-sterile handpiece sheaths labeled as sterile, posing a risk of infection.

    Product
    Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 VOLTS AC, REF/Catalog Number 7-900-115, Rx Only . There is no problem with the Hyfrecator 2000 Electrosurgical Units.…
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    0 states
  • HighFDA (Devices)··2017-04-19

    ConMed Recalls Hyfrecator 2000 Handpiece Sheaths Due to Sterility Labeling Error

    ConMed is recalling Hyfrecator 2000 handpiece sheaths because non-sterile units were packaged in pouches labeled as sterile, posing a risk of infection.

    Product
    HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 2000 Electrosurgical Units or with cases of P/N 7-796-19 sold in cases as P/N…
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    0 states
  • HighFDA (Devices)··2017-04-19

    ConMed Recalls Hyfrecator 2000 Accessory Packages with Non-Sterile Sheaths

    ConMed is recalling Hyfrecator 2000 accessory packages because they contained non-sterile handpiece sheaths labeled as sterile.

    Product
    Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons , 220 VOLTS AC, REF/Catalog Number 7-900-220, Rx Only, There is no problem with the Hyfrecator 2000 Electrosurgical Units…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-04-19

    ConMed Recalls Sterile Handpiece Sheaths Packaged in Error

    ConMed is recalling sterile handpiece sheaths that were packaged in error with non-sterile units. The mislabeling could lead to the use of non-sterile sheaths.

    Product
    Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 100 VOLTS AC, REF/Catalog Number 7-900-100, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Unit. -- ASSEMBLED…
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    Distribution
    0 states
  • HighFDA (Devices)··2017-04-19

    ConMed Recalls Sterile Handpiece Sheaths Packaged as Non-Sterile

    ConMed is recalling sterile handpiece sheaths that were incorrectly packaged with non-sterile units. This error could lead to the use of non-sterile sheaths in medical procedures.

    Product
    Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 230 VOLTS AC, REF/Catalog Number 7-900-230, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED…
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    Distribution
    0 states