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FDA MEDWATCH ALERTS

December 18, 2014

0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter

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FDA MedWatch Recall - Particulate Matter

November 21, 2014

FDA MedWatch - Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur

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FDA MedWatch Respironics California Esprit V1000 and V200 Ventilators Class I Recall

November 21, 2014

FDA MedWatch - Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled

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Highly Concentrated Potassium Chloride Injection 10 mEq per 100 mL by Baxter Recall Mislabeled

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Fisher and Paykel Healthcare Reusable Breathing Circuit Class I Recall - Pinholes in Tubes

Monday, January 07, 2013

AUDIENCE: Risk Manager, Anesthesiology

ISSUE: FDA notified healthcare professionals that the Fisher & Paykel Healthcare Reusable Breathing Circuit, Model 900MR068, was recalled due to pinholes in the tubes used in the reusable breathing circuit. If these pinholes are not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy. Usage of the defective device may result in patient death.

BACKGROUND: The Fisher & Paykel Healthcare Reusable Breathing Circuit is a non-heated breathing circuit intended for oxygen therapy delivery for adult patients.

RECOMMENDATION: On Nov. 19, 2012, Fisher & Paykel issued an Urgent Medical Device Recall letter to inform customers of the problem and to provide them with a Product Recall Response form. Customers should examine their inventory and destroy and discard any affected circuits in their possession.

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.htm
  • 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 Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm334446.htm

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