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Hudson RCI Sheridan Sher-I-Bronch Endobroncial Tube by Teleflex Medical: Class I Recall - Connector May Crack or Separate
AUDIENCE: Risk Manager, Hospital, Nursing, Otolaryngology, Pulmonology
ISSUE: Teleflex Medical has received customer complaints about the endobroncial tube’s double swivel connector. The connector may break or separate on the tube. If this happens, the device may leak, causing the patient to not receive enough oxygen (hypoxia) or experience respiratory distress. This can lead to the need to re-intubate the patient, patient injury or death. See the recall notice for a complete list of affected lot numbers.
BACKGROUND: An endobronchial tube is a plastic tube that is inserted through the mouth into the main passageway into the lungs (bronchi). The tube is used during a medical procedure that determines how well a lung is working (bronchospirometry).
RECOMMENDATION: On June 1, 2015 Telefex Medical sent an Urgent Medical Device Recall Notification to their customers. In that letter they instructed customers to:
- Immediately stop using any affected products
- Quarantine affected products
- Complete the Recall Acknowledgement Form attached to the notification and fax it to 855-419-8507 (Attn: Customer Service) or email to recalls@xxxxxxxxxxxx
- Upon completion of the form, a customer service representative will contact customers to arrange for return of the product, if necessary.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Read the MedWatch Safety Alert, including a link to the Class I Recall notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm459827.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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