Events

Recall of Device Recall Endobronchial Tubes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teleflex Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52823
  • Event Risk Class
    Class 2
  • Event Number
    Z-1944-2009
  • Event Initiated Date
    2009-07-31
  • Event Date Posted
    2009-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84079
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Connector, airway (extension) - Product Code BZA
  • Reason
    The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs.
  • Action
    Teleflex Medical, Inc. notified consignees via overnight mail starting July 31, 2009 requesting acknowledgement of the recall and a request to return all of the affected product. Distributors were instructed to forward the letter to their consignees and retrieve relevant product from those locations. Affected product received by Teleflex Medical will be destroyed or reworked and replacement product or credit will be provided to the consignee. For further information, contact Teleflex Medical at 1-919-433-4986.

Device

Device Recall Endobronchial Tubes
  • Model / Serial
    Catalog Number: V5-16035, Lot Numbers: 1140268, 1140907, 1170555, 1178484, 1183448, 1194376, 1201935, 1208297, 1244546, 1275365, 01A0800182, 01D0800258, 01H0800057 and 01H0800402;   Catalog Number: V5-16037, Lot Numbers: 1145385, 1153622, 1158906, 1160679, 1163824, 1176066, 1182302, 1185569, 1190950, 1193074, 1199354, 1236306, 1246651, 1271778, 1278921, 1280706, 01K0700358, 01B0800201, 01C0800187, 01G0800445, 01J0800075 and 01A0900206;   Catalog Number: V5-16039, Lot Numbers: 1133751, 1152985, 1161068, 1164080, 1170555, 1176067, 1184133, 1191586, 1197169, 1198624, 1214179, 1215134, 1234645, 1266007, 166785, 1268697, 1271779, 01B0800049, 01B0800202, 01C0800352, 01G0800444 and 01A0900241; and   Catalog Number: V5-16041, Lot Numbers: 1167165, 1178485, 1197171, 1205970, 01K0700160 and 01K0800041.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    U.S. Nationwide, Canada, Mexico, Europe, India, Asia Pacific Rim, South and Latin America. (Including: Malaysia, Hong Kong, Vietnam, Singapore, Thailand, Korea, China, Japan, Philippines, Australia, New Zealand, France, Germany, Ireland, Sweden, Costa Rica, Puerto Rico, Jamaica, Brazil, Argentina, Uruguay and Colombia).
  • Product Description
    Hudson RICA¿ Sheridan, EB Tube, Sher-I-Bronch, LS, 35FR, Nova Plus, 37FR, 39 FR, and 41 FR, Teleflex Medical, Research Triangle Park, NC 27709. || Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA