Device Recall Covidien Valley Lab

  • Model / Serial
    Affected Lot Range: 210654X through 61380120X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Product Description
    Valleylab Laparoscopic Curved Spatula Electrode 36CM || Item Code: E277136 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medtronic, 60 Middletown Ave, North Haven CT 06473-3908
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

16 devices with a similar name

Learn more about the data here

  • Model / Serial
    Affected Lot Range: 210141X through 61220104X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Product Description
    Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes || Item Code: E253028 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • Model / Serial
    Affected Lot Range: 210286X through 61220102X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Product Description
    Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" || Item Code: E25306 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • Model / Serial
    Affected Lot Range: 211742X through 60870082X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Product Description
    Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM || Item Code: E258128 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • Model / Serial
    Affected Lot Range: 216416X through 60080002X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Product Description
    Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM || Item Code: E258228 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • Model / Serial
    Affected Lot Range: 210556X through 60520063X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Product Description
    Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm || Item Code: E258328 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
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