Welcome to the all-new Vetlearn

  • Vetlearn is becoming part of NAVC VetFolio.
    Starting in January 2015, Compendium and
    Veterinary Technician articles will be available on
    NAVC VetFolio. VetFolio subscribers will have
    access to not only the journals, but also:
  • Over 500 hours of CE
  • Community forums to discuss tough cases
    and networking with your peers
  • Three years of select NAVC Conference
    Proceedings
  • Free webinars for the entire healthcare team

To access Vetlearn, you must first sign in or register.

registernow

  Sign up now for:
Become a Member

Reference Desk December 2012

Voluntary Worldwide Field Corrective Action Issued for Circuit used on GE Healthcare’s Giraffe and Panda

    December 26, 2012—GE Healthcare initiated a voluntary worldwide field correction of the T-piece circuit used with GE Healthcare’s Giraffe and Panda resuscitation units. The T-piece circuits affected by this recall are sold under the following part numbers and contain a red inspection stamp (those containing a blue inspections stamp are NOT affected by this recall):

    • M1091335 Kit, Circuit, T-Piece Disposable, 10 pack
    • M1091316 Kit, Circuit, T-Piece Disposable, W MASK Size 0, 10 pack
    • M1091365 Kit, Circuit, T-Piece Disposable, W MASK Size 1, 10 pack

    The T-piece circuit used with GE Healthcare’s Giraffe and Panda resuscitation units may impact patient safety. The issue occurs when the T-piece circuit is not able to achieve maximum PIP (Peak Inspiratory Pressure) of 45 +/- 5 cmH[2]O as measured by the built-in Airway Pressure Manometer during the pre-use checkout procedure. The built-in Airway Pressure Manometer of the resuscitation system is not affected by this issue and will accurately display airway pressure. Clinicians should always use the airway pressure manometer to verify Peak Inspiratory Pressure (PIP). The affected units were manufactured from September 10, 2009 to May 10, 2012.

    GE Healthcare initiated the field correction on June 26, 2012, and began notifying customers with affected units through an Urgent Medical Device Correction letter and follow up has been conducted to confirm their receipt of the letter. Through these efforts, approximately 84% of identified customers have confirmed receipt of the safety instructions provided and have also confirmed all affected product has been returned or destroyed. The remaining unconfirmed customers are being contacted directly to resolve and close the issue as soon as possible. Customers have been directed to NOT use the T-piece circuit with the part numbers listed above and to isolate all affected product. To date, no patient injuries have been reported with this issue.

    The U.S. Food and Drug Administration (FDA) has classified this recall as a Class I recall. FDA defines Class I recalls as “a situation in which there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.”

    For additional information regarding this field correction or to arrange return and/or replacement of the product, please contact GE Healthcare Customer Service at 1-800-345-2700.

    Source: FDA

    didyouknow

    Did you know... Although pet owners' top worries revolve around their pets' health and wellness only 34% rated their knowledge of what's best for their pet's health as excellent. Read More

    Stay on top of all our latest content — sign up for the Vetlearn newsletters.
    • More
    Subscribe